Recalls, Tracing and Suspect Products

Introduction

Every bottle on a pharmacy shelf was made in a specific batch and reached the pharmacy through a chain of businesses. Sometimes a problem appears. A manufacturer finds a defect, a package looks wrong, or the paperwork that should come with a shipment is missing.

When that happens, the pharmacy has to answer two questions quickly:

• Which exact units are affected?
• Can we trust where this product came from?

This lesson teaches the routine that answers both. You will learn to read a recall notice, find exactly the units it names, set aside anything suspicious so no patient receives it, and handle the paperwork that follows a drug from seller to pharmacy.

The rules here are United States federal rules, mainly from the Food and Drug Administration (FDA) and a federal law called the Drug Supply Chain Security Act (DSCSA). Your state and your employer may add their own requirements, and federal rules do not cancel those. Throughout, the technician's role is to recognize the problem, keep the product from moving, record what was found, and alert the pharmacist. Clinical and final decisions belong to the pharmacist.

What you will be able to do

1. Tell an FDA recall class from a DEA controlled-substance schedule, and explain what each one describes.
2. Tell a recall from a market withdrawal, and read a recall's status without guessing how risky it is or whether it is finished.
3. Match a recall notice to the exact product, package and lot on your shelf.
4. Respond to a suspect product by quarantining it and supporting the investigation.
5. Choose the correct license or registration check for each kind of business partner, tell that check apart from product tracing, and apply the tracing-document duties to a given transaction.

Before you start: You need everyday reading skills. It also helps to have worked through Read a medicine identity before learning a name and Read NDC segments and directory limitations. Terms you need are defined here when they first appear.

Recall classes and DEA schedules answer different questions

The short version: An FDA recall class tells you how likely it is that using one specific defective product will hurt someone, and how badly. A DEA schedule tells you how tightly the drug substance itself is controlled. Both systems use Roman numerals, which is why people mix them up. They describe completely different things.

What a recall is

A recall is an action a company takes to remove a product from the market. A company may also use a recall to warn patients about a potential risk. A recall can start on the company's own initiative, at FDA's request, or by FDA order.

FDA sorts recalls into three classes by health risk:

• Class I: There is a reasonable probability that using or being exposed to the product will cause serious harm to health, or death.
• Class II: Using the product may cause harm that is temporary or medically reversible, or the chance of serious harm is remote.
• Class III: Using the product is not likely to cause any harm to health.

Class I is the most serious, so a lower number means a higher risk.

What a DEA schedule is

The Drug Enforcement Administration (DEA) places controlled substances into five schedules, numbered I through V. The schedule depends on two things: whether the substance has an accepted medical use, and how likely it is to be abused or to cause dependence.

• Schedule I substances have no currently accepted medical use and a high potential for abuse.
• Schedule V substances have the lowest abuse potential of the five.

The lesson Controlled-substance schedules and valid orders covers schedules in detail.

Why the two never substitute for each other

• A recall class belongs to a recall situation: one defect in particular lots of one product.
• A schedule belongs to a substance, whether or not any bottle of it is defective.

A recall does not change a drug's schedule. A schedule tells you nothing about how dangerous a particular defect is.

Worked example. A fictional notice reads: "Class II recall. Fictional Pharma Co. tablets, lot A2210. Some labels may have smudged strength printing." A coworker says, "Class II, like Schedule II. Lock it in the controlled-substance cabinet."

That reasoning mixes up the two systems:

• "Class II" describes the health risk of this labeling defect.
• Whether the product needs controlled-substance storage depends on whether the drug is a controlled substance. That is a separate fact, found on the product and in the pharmacy's records.
• What to do with the recalled units comes from the recall notice's instructions.

Change one fact. Suppose the same product's defect instead creates a reasonable probability of serious harm or death. The recall becomes Class I. The drug's schedule, or its non-controlled status, stays exactly the same.

Now reverse the situation. A Schedule II drug has a Class III recall. The drug still needs every controlled-substance procedure. The Class III label only says that this particular defect is not likely to cause harm. A mild recall class does not relax controlled-substance handling, and a strict schedule does not make a recall more serious.

Question 1

A Schedule IV medicine is subject to a Class I recall. A new technician says this cannot be right, because "Schedule IV drugs are low-risk, so their recalls should be low class too." What is wrong with this reasoning?

Market withdrawals and recall status

The short version: A market withdrawal is a removal for a minor problem. It is not a fourth recall class. A recall's status tells you how far FDA's oversight of the removal effort has gone. Neither label tells you that a unit in your hands is fine to use.

Market withdrawals

A market withdrawal happens when a product has a minor violation that would not be subject to FDA legal action. The company removes the product from the market or corrects the problem.

FDA's example is a product removed because of tampering, when there is no evidence of manufacturing or distribution problems. The withdrawal label describes the regulatory situation, which is a minor violation. It does not tell you that any particular package is safe. A tampered package is still something to set aside and show the pharmacist. You still follow the company's instructions.

Recall status

FDA's public recall list can mark a recall as terminated. That means FDA has determined two things:

• All reasonable efforts have been made to remove or correct the product according to the recall plan.
• The product has been properly dealt with according to its level of hazard.

Recalls that are not marked terminated are either ongoing or completed. The listing alone does not tell you which.

This leads to two common mistakes:

• "No terminated mark, so it is definitely still ongoing." Not necessarily. It may already be completed.
• "It says terminated, so the recalled lot is fine now." Termination is FDA's judgment that the removal effort is finished. It is not a statement that the recalled lot is acceptable to use.

If you find a recalled unit after the fact, follow the recall instructions and ask the pharmacist. Do not reason from the status label.

Question 2

A product is removed through a market withdrawal. A technician concludes, "Withdrawal means it's harmless and the company is done, so I'll leave the units on the shelf." Identify two errors.

Match the notice to the exact units

The short version: A recall usually names specific lots of a specific product in a specific package. Only units that match every identifier in the notice are covered. "Same drug name" is not a match.

Terms you need

• Lot: A batch of a drug, or an identified portion of a batch, made to have uniform character and quality.
• Lot number: A code of letters, numbers or symbols. From it, the complete history of how that lot was made, processed, packed, stored and distributed can be traced.
• NDC (National Drug Code): FDA's three-segment identifier for a listed drug product. The NDC identifies the product. It does not identify the lot. Having an NDC also does not mean FDA approved the product.

Why every identifier must match

A defect usually comes from how one batch was made, packed or stored. That is why notices name lots.

• A different lot of the same product may not be affected.
• A different strength or package size is a different product, even if it has the same active ingredient.

Federal recall guidance tells companies to identify the product, size, lot numbers, and any codes or serial numbers clearly enough that recipients can identify the product accurately and immediately. A notice should also:

• say that further distribution or use should stop immediately
• explain the reason for the recall
• give specific instructions
• give recipients a way to report whether they have any of the product

Recipients are expected to carry out those instructions right away. Where necessary, they must pass the recall on to their own customers.

A typical matching process

Your pharmacy's written procedure controls the details. A common sequence looks like this:

1. Read every identifier in the notice. This includes the product name, strength, dosage form, package size, NDC if given, lot numbers, and any codes or serial numbers.
2. Search everywhere stock might be. Check wherever your procedure says to look, such as main shelves, overstock, and prescriptions filled but not yet picked up.
3. Compare each unit field by field, character by character. Lot numbers can differ by a single character.
4. Handle units that match every field. Stop their use, set them aside as the notice instructs, label them, and record the count.
5. Leave non-matching units in stock. Record that you checked them.
6. Tell the pharmacist when anything is unclear or only partly matches.
7. Respond to the recalling company as the notice directs. The notice asks whether you have any of the product, so follow its instructions even when the answer is zero.

Decisions about contacting patients belong to the pharmacist and follow the notice's instructions.

Worked example

This notice is fictional, and the NDC is a placeholder.

Fictional Pharma Co. recall: lisinopril 10 mg tablets, 90-count bottles, NDC 00000-1111-09, lots K4471 and K4472.

Here is what is on the shelf:

Unit D is a partial match. Do not decide it alone. Set it aside if your procedure allows, and tell the pharmacist, who can confirm with the company.

Change one fact. Suppose the notice says "all lots" instead of listing two. Now every 10 mg 90-count bottle with that NDC matches, whatever its lot number. Unit B becomes a match. Unit C still does not, because it is a different product.

When a patient reports feeling unwell

A patient calls to say they felt unwell after taking medicine from a recalled lot. The recall does not prove that the medicine caused the problem. The absence of a recall would not rule the medicine out either. Record what the patient reports and bring it to the pharmacist. Do not tell the patient whether the medicine caused it.

Question 3

A fictional notice names "amoxicillin 250 mg/5 mL powder for oral suspension, 100 mL bottle, lot R0093." On your shelf you find:

• amoxicillin 500 mg capsules, lot R0093
• amoxicillin 250 mg/5 mL suspension, 100 mL, lot R0039
• amoxicillin 250 mg/5 mL suspension, 100 mL, lot R0093

Which units match?

Suspect product: quarantine and investigate

The short version: If you have reason to think a product may be fake, stolen or tampered with, stop it from moving. Set it apart where no one can dispense or sell it, and let the pharmacy's investigation decide what it is.

Terms you need

• Suspect product: A prescription drug that may be counterfeit, diverted, stolen, intentionally adulterated, or unfit for distribution.
• Illegitimate product: A drug with evidence that it is one of those things.

The words in those definitions mean:

• Counterfeit: fake.
• Diverted: moved out of the legitimate supply chain.
• Intentionally adulterated: deliberately contaminated or altered.
• Unfit for distribution: not suitable to be passed along to anyone.

Quarantine means physically separating the product and clearly labeling it, so no one dispenses or sells it while the questions are answered.

What federal rules require

Pharmacies must have a process to handle suspect and illegitimate drugs. The process includes these steps:

1. Quarantine and investigate suspect product to determine whether it is illegitimate.
2. If it is illegitimate, work with the manufacturer and take steps to make sure patients do not receive it.
3. Notify FDA, and notify the immediate trading partners the pharmacy has reason to believe may have received the illegitimate product, no later than 24 hours after determining that the product is illegitimate. FDA expects these partners to include those the pharmacy sold the drug to and, in some cases, the one it bought the drug from.

FDA guidance recommends that investigators look closely at the package and labeling and consult the manufacturer. The pharmacist or the pharmacy's designated process leads the investigation and handles the notifications.

When the 24-hour clock starts

The two stages carry different duties:

• Suspicion: When there is reason to believe a product may be illegitimate, the pharmacy quarantines it and promptly investigates. Suspicion, quarantine and the investigation itself do not start the 24-hour notification clock.
• Determination: The clock starts when the pharmacy determines that the product is illegitimate. FDA and the immediate trading partners must then be notified within 24 hours.

This 24-hour deadline belongs to illegitimate-product determinations. It is not a federal deadline for every suspicion, and it is not the rule for responding to a recall. Recalls follow the recall notice's instructions.

What counts as a warning sign

FDA guidance describes scenarios that raise the risk of suspect product, such as questionable or incomplete transaction information. FDA says these examples are illustrative, not a complete list. Pharmacies should weigh the surrounding circumstances, including whether several warning signs appear together.

That has two consequences:

• A missing warning sign does not clear a product. If something seems wrong and it is not on any list you have seen, still report it.
• One oddity is not proof that a product is illegitimate. It is a reason to look closer.

The technician's part

1. Do not shelve, dispense or sell the product.
2. Quarantine it according to your procedure.
3. Keep the original packaging and documents. Do not throw anything away.
4. Tell the pharmacist promptly what you noticed.

The technician does not decide whether a product is illegitimate and does not send the notifications. Prompt escalation matters because it lets the investigation start quickly.

Worked example

A shipment arrives from the pharmacy's usual wholesaler. You notice three things:

• One bottle's label has a misspelling.
• Its seal looks re-glued.
• The lot number printed on the bottle does not appear on the shipment's documents.

You do not shelve it. You place it in quarantine with a clear label, keep the tote and paperwork together, and tell the pharmacist right away.

A coworker says, "The barcode scanned as the right NDC, so it's real." But an NDC match only shows that the printed code is the expected code for that product. It does not show that this particular package is genuine, and codes can be copied. The scan does not answer the questions that the seal and the lot number raise.

At this point the bottle is suspect, not illegitimate. Quarantining it and starting the investigation do not start the 24-hour notification clock.

Change one fact. Suppose the pharmacist's investigation, with the manufacturer's help, finds evidence that the bottle is counterfeit. It is now illegitimate, and that determination starts the 24-hour clock. The pharmacy works with the manufacturer to make sure no patient receives it. Through the pharmacist or the pharmacy's designated process, it notifies FDA and the immediate trading partners it has reason to believe may have received the product, no later than 24 hours after the determination.

If instead the investigation finds that the bottle is not illegitimate, the pharmacist follows the pharmacy's process for what happens next.

Recall or suspect product?

Both situations can end with product in quarantine, but they start differently and lead to different follow-up:

• A recall starts when the company tells you that identified lots have a problem. You follow its instructions.
• A suspect product starts when someone at the pharmacy has reason to doubt a product. It leads to an investigation and, if the product is determined to be illegitimate, to notifications within 24 hours of that determination.

Question 4

A box of tablets arrives with an intact seal and a clean label. The only odd thing is that the tablets inside are a different color from every previous shipment of this product. None of the warning signs your coworker memorized mention tablet color. Should you treat the product as normal stock?

Check the business partner, then check the paperwork

The short version: These are two different checks.

• The authorization check asks: Is this business allowed to do what it is doing?
• Product tracing asks: Where did this specific shipment come from, and does the required paperwork come with it?

Passing one check does not mean you have passed the other.

Trading partners and the authorization check

Trading partners are the businesses a pharmacy deals with in the drug supply chain: manufacturers, repackagers, wholesale distributors, third-party logistics providers, and other pharmacies. A third-party logistics provider is a company that stores or ships drugs for others.

Each kind of business is checked in a different way:

• Manufacturer or repackager: check its FDA registration.
• Wholesale distributor or third-party logistics provider: check its license.
• Pharmacy: check its license through that state's licensing authority.

Choose the check by what kind of business it is, not by what it is selling.

Why authorization and tracing are separate checks

• A properly licensed wholesaler can still send a shipment with missing documents. Authorization does not prove that the paperwork is complete.
• A seller with complete-looking documents but no valid license is still not an authorized partner. The paperwork does not create authorization.

Product tracing duties

Product tracing documentation is the information that travels with a prescription drug as it moves between businesses, showing the path of that transaction. Under DSCSA, pharmacies must do three things.

1. When receiving: Accept prescription drugs only if they come with product tracing documentation. If the seller did not provide all of it, work with the seller promptly to get the missing parts. An invoice alone does not show that the documentation is complete. Missing documentation does not by itself prove a product is illegitimate. It is a reason to follow up and to consider the surrounding circumstances. Follow your pharmacist's direction on how the product is held in the meantime.
2. When storing: Keep the tracing documentation you receive for six years.
3. When selling a prescription drug to a trading partner: Generate the tracing documentation and provide all of it with the transaction.

Two exceptions apply to that third duty. You do not need to provide tracing documentation when you:

• dispense a prescription drug to a patient, or
• sell to another pharmacy so that pharmacy can dispense to a specific patient.

State rules and employer procedures may add requirements beyond these federal duties.

Worked example: three transactions

1. A wholesaler delivers a shipment, but the documentation for one item is missing. You do not quietly shelve that item. You tell the pharmacist, who works with the wholesaler promptly to get the missing documentation.
2. A patient picks up a filled prescription. No tracing documentation goes to the patient. Dispensing to a patient is an exception.
3. Another pharmacy asks to buy a bottle to restock its shelves. That pharmacy is a trading partner, and this sale is not for a specific patient. Your pharmacy must provide all tracing documentation with the transaction.

Change one fact in transaction 3. The other pharmacy needs the bottle to fill one specific patient's prescription. Now the exception applies, and tracing documentation is not required for that sale under the federal rule. Your state's rules still apply.

Question 5

Your pharmacy is considering buying from three new businesses: a repackager, a third-party logistics provider, and another pharmacy. Which check applies to each?

Question 6

A technician says, "This wholesaler is fully licensed. I checked last month. So we don't need to worry that today's delivery came with only an invoice." What is wrong?

Independent practice

Work through each question before opening its answer.

Question 7

A notice announces a Class III recall of specific lots of a Schedule IV tablet. A coworker suggests continuing to dispense the affected lots until next week's inventory day, "since Class III is minor." What should happen?

Question 8

A fictional notice names "metoprolol tartrate 25 mg tablets, 100-count bottle, all lots." On your shelf you find:

• metoprolol tartrate 25 mg, 100-count, lot P118
• metoprolol tartrate 25 mg, 100-count, lot P220
• metoprolol succinate extended-release 25 mg, 100-count, lot P118

Which units are covered?

Question 9

You have quarantined bottles from a recalled lot. A coworker checks FDA's recall list, sees that the recall is not marked terminated, and says, "Then the recall must be complete. Put the bottles back." Evaluate this.

Question 10

A new seller offers a popular product at an unusually low price. Its shipment arrives with tracing documents that look complete. When you search for the seller's wholesale distributor license, you cannot find one. The seller says, "Our paperwork proves we're legitimate." What do you do, and why?

Question 11

A manager wants to shred a box of tracing documentation the pharmacy received four years ago to free up space. Separately, your pharmacy sells a bottle to a nearby pharmacy so that pharmacy can fill one specific patient's prescription. Which federal tracing duties apply?

Question 12

A patient says they had a stomach upset after starting tablets that you now see belong to a recalled lot. A coworker tells the patient, "That's definitely from the recall." Was that the right response?

What to remember

• Recall class describes the health risk of one recall situation. Class I is the most serious. DEA schedule describes how a substance is controlled, based on medical use and abuse potential. One never tells you the other.
• A market withdrawal is a removal or correction for a minor violation. It is not a recall class, and it does not promise that every unit is safe.
• Recall status: "Terminated" means FDA judged the removal effort complete. A recall without that mark may be ongoing or completed. Neither status makes a recalled unit usable.
• Matching: Match every identifier in the notice, including product, strength, form, package size, NDC and lot. The same ingredient is not the same product. When something only partly matches, escalate it.
• Suspect product: Quarantine it, keep its packaging and paperwork, and tell the pharmacist promptly. Warning-sign lists are examples, not a complete set. Suspicion leads to quarantine and a prompt investigation. A determination that the product is illegitimate leads to work with the manufacturer and notification of FDA and the immediate trading partners that may have received it, no later than 24 hours after that determination. The pharmacist or designated process handles the notifications. This 24-hour deadline does not apply to mere suspicion or to recalls.
• Authorization: Check FDA registration for manufacturers and repackagers. Check licenses for wholesale distributors and third-party logistics providers. Check pharmacies' licenses through that state's licensing authority. Tracing is a separate check on each shipment's paperwork.
• Tracing duties: Accept prescription drugs only with tracing documentation, and follow up promptly on anything missing. Keep received documentation for six years. Provide documentation when selling to a trading partner, except when dispensing to a patient or selling to a pharmacy for a specific patient.
• Federal rules sit alongside state and employer rules; they do not replace them.

Review: A product receipt needs its tracing information

• Check the business partner, then check the paperwork

Review: Distinguish a trading-partner sale from patient dispensing

• Check the business partner, then check the paperwork

Review: Identify the record before choosing a retention period

• Check the business partner, then check the paperwork

Review: Read recall termination as a status determination

• Market withdrawals and recall status

Review: Pause and predict

• Match the notice to the exact units

Review: Trace where the product came from

• Suspect product: quarantine and investigate
• Check the business partner, then check the paperwork