Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 100 ml (when mixed) ...
FDA Recall #D-0178-2021 — Class II — December 17, 2020
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
Recalling Firm
Ascend Laboratories LLC — Parsippany, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
29,317 bottles
Distribution
Nationwide
Code Information
20141674, 20141675, 20141676, 20141677, 20141678,
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated