D-0178-2021 Class II Terminated
FDA drug recall D-0178-2021 was initiated by Ascend Laboratories LLC on December 17, 2020 and is designated Class II. Reason for recall: Failed Impurity/Degradation Specifications The recall status is terminated (terminated May 3, 2023). Affected quantity: 29,317 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 6, 2021
- Initiation Date
- December 17, 2020
- Termination Date
- May 3, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29,317 bottles
Product Description
Ascend Laboratories, llc 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
Failed Impurity/Degradation Specifications
Distribution Pattern
Nationwide
Code Information
20141674, 20141675, 20141676, 20141677, 20141678,