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Additional Recalls for Antibiotic

January 15, 2021

More cephalexin products have been voluntarily recalled by Ascend Laboratories after unidentified impurities were observed in the product, according to the January 13, 2021, US Food and Drug Administration (FDA) Enforcement Report.

The most recently announced recalls affect cephalexin for oral suspension, 125 mg per 5 mL, packaged in:

  • 100-mL (when mixed) bottles (NDC 67877-544-88), from lots 19144340 and 19144341 (Exp 8/21); and
  • 200-mL (when mixed) bottles (NDC 67877-544-68), from lots 20142226 and 20142227 (Exp. 5/22). 

The products were manufactured by Alkem Laboratories and distributed by Ascend Laboratories throughout the United States. 

Ascend Laboratories initiated the recall November 23, 2020. The FDA designated the recall Class II on January 4, 2021, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists. 

Cephalexin is a prescription cephalosporin antibiotic used to treat a wide variety of bacterial infections.

Jolynn Tumolo

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