Expired and Recalled Products

FDA Approval Process and Expiration Dates

  • The FDA collaborates with manufacturers to establish expiration dates for medications.

  • It's essential to check expiration dates on all products before dispensing to ensure that prescriptions are likely to be used prior to their expiration.

  • Upon receiving new inventory, evaluate expiration dates on all items, including those currently in stock.

  • Expired medications must be removed from shelves according to pharmacy protocols.

  • Expiration dates can vary based on storage environments.

Examples of Expiration Date Changes

  • Famotidine Vials for Injection:

    • Manufacturer expiration date applies under controlled refrigerated temperatures.

    • Once removed from refrigeration, expiration changes to months at room temperature.

  • Insulin:

    • Manufacturer expiration date applies when refrigerated.

    • At room temperature, the expiration is shortened to 28 days.

  • Expired medications should be securely stored for disposal.

Disposal of Expired Medications

  • For controlled substances, follow additional steps:

    1. Remove from perpetual inventory log.

    2. Complete a DEA Form 41 for disposal.

    3. Require two witnesses for disposal.

  • Companies can hire reverse distributors to manage documentation and disposal of expired medications.

  • Some pharmacies may receive credits for returning expired medications.

Adverse Effects and Recalls

  • The FDA receives reports of adverse effects or misbranding via the MedWatch program, allowing healthcare professionals and consumers to report concerns.

  • If a product poses a public health threat, the FDA will contact the manufacturer to recommend a recall.

Classes of Recall

  • Class I Recall:

    • Serious adverse effects or death highly likely.

  • Class II Recall:

    • Temporary, reversible adverse effects possible; little chance of serious effects.

  • Class III Recall:

    • Problems unlikely to cause adverse effects.

  • Medication manufacturers can also voluntarily recall products from the market.

Recall Notifications

  • Once a recall is issued, a formal letter is sent to wholesalers, sellers, and customers, marked Urgent Product Recall.

  • The recall letter includes:

    • Class of recall.

    • Reason for the recall.

    • Description of recalled products (NDC number, lot number, package size).

  • The lot number is critical for identifying specific batches associated with the recall.

Pharmacy Actions During Recalls

  • Medications included in recalls must be removed from inventory and addressed in accordance with the recall letter.

  • Recalled items must be pulled from floor stock and automated dispensing machines in hospitals.

  • In some cases, manufacturers request that recalled products be returned for inspection, or simply destroyed.

  • Not all recalls require patient notification; however, Class I recalls require notification to patients for medication returns and refunds.

  • Media involvement may be necessary to ensure communication reaches patients effectively.