Drug product
Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL per bottle, Rx Only, Distr. by: West-Ward Pharmaceuticals,Eatontown, NJ. NDC:0054-0199-59
D-1863-2019
Product summary
- Event
- Event 83698
- Status
- Terminated
- Classification
- Class II
- Quantity
- 32,347 bottles
- Official record key
drug-enforcement:D-1863-2019
Official wording
Reason: Failed Impurities/Degradation Specificattion
Code information: Lot, expiry: Lots AA3957A, AA3958A, exp May 2020; Lot AA5164A, exp Sep 2020
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Unknown
Failed Impurities/Degradation Specificattion