Recalls / Class II
Class IID-1087-2014
Product
Clonazepam Tablets, USP 2 mg 100 tablets Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue, Elizabeth, NJ 0737 USA NDC 0228-3005-11 packaged in White/Round HDPE 75 CC with white/round plastic 33 mm CRC closure shipped in corrugated 75 cc carton (24 bottles/carton)
- Affected lot / code info
- lot 58468552 Exp. 05/15
Why it was recalled
Subpotent Drug: During routine stability testing one tablet was found with tablet weight below specification.
Recalling firm
- Firm
- Actavis Elizabeth LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 200 Elmora Ave, Elizabeth, New Jersey 07202-1106
Distribution
- Quantity
- 13,608 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-11-06
- FDA classified
- 2014-02-21
- Posted by FDA
- 2014-03-05
- Terminated
- 2014-06-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1087-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.