Class II
Terminated
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
This recall has been terminated (originally issued January 13, 2021).
- Company
- Ascend Laboratories, Llc
- Recall Initiated
- November 23, 2020
- Posted
- January 13, 2021
- Recall Number
- D-0185-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 20,232 bottles
- Firm Location
- Parsippany, NJ, United States
- Official Source
- View on FDA website ↗
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.
Distribution
Distributed Nationwide in the USA
Lot / Code Info
Lot#: a) 19144340, 19144341, Exp AUG 2021; b) 20142226, 20142227, Exp MAY 2022
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