Recalls / Class II
Class IID-1495-2016
Product
Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-9060-31- (Single Use Container), NDC# 0703-9060-33 (Box of 10 Singe Use Containers)
- Affected lot / code info
- All Lots Within Expiry
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Teva North America
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 425 Privet Rd, Horsham, Pennsylvania 19044-1220
Distribution
- Quantity
- 92,480 containers
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-06-17
- FDA classified
- 2016-09-07
- Posted by FDA
- 2016-09-14
- Terminated
- 2017-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1495-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.