Drug product
Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Jeedimetla,Hyderabad - 500 055, India, NDC 31722-574-47
D-0099-2018
Product summary
- Event
- Event 78287
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4050 bottles
- Official record key
drug-enforcement:D-0099-2018
Official wording
Reason: Presence of foreign substance (screw)
Code information: Lot # E170346, Exp 02/19
Distribution pattern: NJ
Derived failure modes
-
Foreign material or chemical contamination
foreign substance