Recalls / Class II
Class IID-0868-2016
Product
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
- Affected lot / code info
- Lot # 2520715, Exp Date: 7/17
Why it was recalled
Lack of Assurance of Sterility: Due to potential for leaking bags.
Recalling firm
- Firm
- Teva North America
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 425 Privet Rd, N/A, Horsham, Pennsylvania 19044-1220
Distribution
- Quantity
- 546 bags
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-04-27
- FDA classified
- 2016-05-24
- Posted by FDA
- 2016-06-01
- Terminated
- 2018-02-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0868-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.