Drug product
Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-88
D-0263-2021
Product summary
- Event
- Event 87214
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14,205 100 mL bottles
- Official record key
drug-enforcement:D-0263-2021
Official wording
Reason: CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Code information: Lot # 19144841, Exp 9/2021; 20141673 Exp 4/2022.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations