D-0263-2021 Class II Terminated
FDA drug recall D-0263-2021 was initiated by Ascend Laboratories LLC on January 22, 2021 and is designated Class II. Reason for recall: CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit. The recall status is terminated (terminated December 2, 2022). Affected quantity: 14,205 100 mL bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 24, 2021
- Initiation Date
- January 22, 2021
- Termination Date
- December 2, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,205 100 mL bottles
Product Description
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
Reason for Recall
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Distribution Pattern
Nationwide in the USA
Code Information
Lot # 19144841, Exp 9/2021; 20141673 Exp 4/2022.