Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial ...
FDA Drug Recall #D-0756-2023 — Class III — May 8, 2023
Recall Summary
| Recall Number | D-0756-2023 |
| Classification | Class III — Low risk |
| Date Initiated | May 8, 2023 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Amneal Pharmaceuticals of New York, LLC |
| Location | Brookhaven, NY |
| Product Type | Drugs |
| Quantity | 69,239 vials |
Product Description
Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injection Only, Not for Intravenous Use, 1 mL Single Dose Vial, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Parenteral Unit, Ahmedabad 382213, India, Amneal Pharamceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1574-01.
Reason for Recall
Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number 70121-1573-1; Correct NDC Number 70121-1574-1.
Distribution Pattern
Nationwide in the USA and PR
Lot / Code Information
Lot Numbers: AP220481, Exp 09/2024; AP220536A, Exp 10/2024
Other Recalls from Amneal Pharmaceuticals of New York, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0477-2024 | Class II | Methylergonovine Maleate Tablets, USP, 0.2mg, 1... | Mar 25, 2024 |
| D-0442-2024 | Class I | Vancomycin Hydrochloride for Oral Solution, USP... | Mar 21, 2024 |
| D-0327-2024 | Class II | Oseltamivir Phosphate for Oral Suspension 6mg/m... | Feb 13, 2024 |
| D-0319-2024 | Class II | Phenoxybenzamine Hydrochloride Capsules, USP 10... | Jan 15, 2024 |
| D-0426-2024 | Class II | Divalproex Sodium Extended-release Tablets, USP... | Dec 26, 2023 |
Frequently Asked Questions
Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced 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.