Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), packaged in 10 x...

FDA Drug Recall #D-0868-2016 — Class II — April 27, 2016

Recall Summary

Recall Number D-0868-2016
Classification Class II — Moderate risk
Date Initiated April 27, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Teva North America
Location Horsham, PA
Product Type Drugs
Quantity 546 bags

Product Description

Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), packaged in 10 x 300 mL Single Use Container bags per Box Pack (NDC 0703-9060-33), Rx only, Manufactured In Hungary By: Teva Pharmaceutical Works Ltd., Hungary, H-2100 Godollo, Tancsics M. ut 82 Hungary; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454

Reason for Recall

Lack of Assurance of Sterility: Due to potential for leaking bags.

Distribution Pattern

Nationwide

Lot / Code Information

Lot # 2520715, Exp Date: 7/17

Other Recalls from Teva North America

Recall # Classification Product Date
D-0005-2017 Class III Claravis (isotretinoin capsules USP), 10mg, pa... Aug 5, 2016
D-1453-2016 Class III Children's Qnasl 40 mcg (beclomethasone dipropi... Jul 15, 2016
D-1470-2016 Class II Amoxicillin for Oral Suspension USP, 400 mg/ 5 ... Jun 24, 2016
D-1455-2016 Class II Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bot... Jun 22, 2016
D-1494-2016 Class II ARGATROBAN Injection in 0.9% Sodium Chloride 25... Jun 17, 2016

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.