FDA-Drug2025-06-18Class II
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-68
Ascend Laboratories, LLC
Hazard
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Sold states
Nationwide in the USA.
Affected count
10,620 - 200 mL bottles
Manufactured in
339 Jefferson Rd Ste 101, Parsippany, NJ, United States
Products
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-68
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0469-2025Don't want to check this manually?
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