Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1 mL vials (NDC 59676...

FDA Drug Recall #D-1173-2017 — Class II — September 13, 2017

Recall Summary

Recall Number D-1173-2017
Classification Class II — Moderate risk
Date Initiated September 13, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Amgen, Inc.
Location Thousand Oaks, CA
Product Type Drugs
Quantity 275,380 vials

Product Description

Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1 mL vials (NDC 59676-310-01), b) box of 25 single use 1 mL vials (NDC 59676-310-02), Rx Only, Manufactured by: Amgen, Inc. Thousand Oaks, CA 91320, Manufactured for: Janssen Products, LP Horsham, PA 19044

Reason for Recall

Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.

Distribution Pattern

U.S.A. Nationwide

Lot / Code Information

Lot #: a) G290530A, Exp 07/18; b) G290531A, Exp 07/18

Other Recalls from Amgen, Inc.

Recall # Classification Product Date
D-0285-2025 Class II Neupogen (filgrastim) For Injection, 300mcg/1 m... Feb 27, 2025
D-0286-2025 Class II Neupogen (filgrastim) For Injection, 480 mcg/1.... Feb 27, 2025
D-0855-2022 Class II MVASI (bevacizumab-awwb), Injection, For Intrav... May 2, 2022
D-1086-2017 Class II Procrit Epoetin Alfa 40,000 units/mL single use... Aug 4, 2017
D-0226-2017 Class II AMGEN Kyprolis (carfilzomib) for injection, 30 ... Dec 15, 2016

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.