Ascend Laboratories, llc 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
FDA recall notice · announced January 6, 2021 · Ascend Laboratories
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
Ascend Laboratories, llc 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
Reason for recall
Failed Impurity/Degradation Specifications
Notes
Distribution: Nationwide
Lot/code information: 20141680, 20141681, 20141759
Quantity: 9,524 bottles
Status: Terminated
Products in this recall event:
- 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 Laborato (D-0178-2021)
- Ascend Laboratories, llc 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 Laborato (D-0179-2021)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.