FDAFDA · Food and drugs·Recall number D-0264-2021
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
Published February 24, 2021 · Recall initiated: January 22, 2021
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
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Brand
- CEPHALEXIN
- Manufacturer
- Ascend Laboratories LLC
- Distributor
- Nationwide in the USA
- Lot
- Lot #: 19141869, 19141870, EXP 3/2021; 19142762, EXP 5/2021; 19143826, 19143923,19143941, 19143954 EXP 7/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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