FDA-Drug2021-02-24Class II
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
Ascend Laboratories LLC
Hazard
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Sold states
Nationwide in the USA
Affected count
23,436 200 mL bottles
Manufactured in
339 Jefferson Rd Ste 101, N/A, Parsippany, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0264-2021Don't want to check this manually?
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