Drug 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)
D-1087-2014
Product summary
- Event
- Event 67053
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,608 bottles
- Official record key
drug-enforcement:D-1087-2014
Official wording
Reason: Subpotent Drug: During routine stability testing one tablet was found with tablet weight below specification.
Code information: lot 58468552 Exp. 05/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent