MethyIPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, 1 mL Single-Dose Vial (NDC 0703...

FDA Drug Recall #D-0275-2021 — Class II — February 10, 2021

Recall Summary

Recall Number D-0275-2021
Classification Class II — Moderate risk
Date Initiated February 10, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Teva Pharmaceuticals USA
Location Parsippany, NJ
Product Type Drugs
Quantity 5,086 vials

Product Description

MethyIPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0031-01), packaged in 25X1ML per tray (NDC 0703-0031-04), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.

Reason for Recall

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.

Distribution Pattern

Product was distributed nationwide in the USA and Puerto Rico.

Lot / Code Information

Lot # 31327742B, exp. date 02/2021 Lot # 31328408B, exp. date 07/2021

Other Recalls from Teva Pharmaceuticals USA

Recall # Classification Product Date
D-0461-2022 Class II Doxylamine Succinate and Pyridoxine Hydrochlori... Jan 18, 2022
D-0520-2022 Class II Tretinoin Capsules, 10 mg, 100 count bottle, Rx... Jan 10, 2022
D-0522-2022 Class III Mimvey (estradiol and norethindrone acetate tab... Jan 7, 2022
D-0521-2022 Class III Mimvey (estradiol and norethindrone acetate tab... Jan 7, 2022
D-0370-2022 Class II MethylPREDNISolone Acetate Injectable Suspensio... Dec 31, 2021

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

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.