Drug product
Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-68
D-0264-2021
Product summary
- Event
- Event 87214
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23,436 200 mL bottles
- Official record key
drug-enforcement:D-0264-2021
Official wording
Reason: CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Code information: Lot #: 19141869, 19141870, EXP 3/2021; 19142762, EXP 5/2021; 19143826, 19143923,19143941, 19143954 EXP 7/2021
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations