FDAFDA · Food and drugs·Recall number D-0185-2021
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
Published January 13, 2021 · Recall initiated: November 23, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Brand
- CEPHALEXIN
- Manufacturer
- Ascend Laboratories LLC
- Distributor
- Distributed Nationwide in the USA
- Lot
- Lot#: a) 19144340, 19144341, Exp AUG 2021; b) 20142226, 20142227, Exp MAY 2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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