November 2020 FDA Recall Cephalexin by Ascend Laboratories Llc
D-0185-2021 - Failed Impurity/Degradation Specifications

This Class II drug recall was voluntarily initiated by Ascend Laboratories Llc on November 23, 2020 for the product Cephalexin. The FDA reported the reason for recall as failed impurity/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0185-2021

Reason for Recall
Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL.
Initiated
11-23-2020
Reported
01-13-2021
Quantity
20,232 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86850
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ascend Laboratories LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-01-2023
Product Description About Product Description
Full technical description of the product.
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, packaged as a) 100 ml (when mixed) bottle, NDC 67877-544-88; b) 200 ml (when mixed) bottle NDC 67877-544-68, Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA. Distributed by: Ascend Lab,oratories, LLC Parsippany, NJ 07054

Batch or Lot Expiration Information

Lot# : a) 19144340, 19144341, Exp AUG 2021; b) 20142226, 20142227, Exp MAY 2022

Affected Packages Involved in this Recall

67877-544-88 Cephalexin
67877-544-68 Cephalexin
67877-545-88 Cephalexin
67877-545-68 Cephalexin