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Mislabeled Antibiotics Recalled
Bryant Ranch Prepack Inc. is recalling 456 bottles of cephalexin for oral suspension due to various labeling errors, according to the June 12, 2024, US Food and Drug Administration (FDA) Enforcement Report.
The following cephalexin products, which were distributed throughout the United States, are included in the recall:
- cephalexin for oral suspension, 125 mg per 5 mL (NDC 63629-9204-1), from lots 225541, 226866, 227369, 227519, 229845, 231422, and 234889 (Exp. 3/31/25). The product’s front label states “100 tablets” instead of “100 mL,” the FDA reported. The back label states, “each tablet contains” instead of “each bottle contains” and fails to list the total dose per bottle, which is 2.5 g. The product was relabeled by Bryant Ranch Prepack Inc., Burbank, California.
- cephalexin for oral suspension, 125 mg per 5 mL, 200 mL when mixed (NDC 63629-9205-1), from lot 234892 (Exp. 2/28/25). The product’s back label states “each contains: cephalexin monohydrate, USP equivalent to 2.5 g” instead of “each bottle contains: cephalexin monohydrate, USP equivalent to 5 g.” The product was manufactured by Alkem Laboratories Ltd. and relabeled by Bryant Ranch Prepack Inc., Burbank, California.
- cephalexin for oral suspension, 250 mg per 5 mL, 200 mL when mixed (NDC 63629-8858-1), from lots 235287, 235629, 235805, 236292, 237022, 237308, and 237748 (Exp. 12/31/25). The product’s back label states “each contains: cephalexin monohydrate, USP equivalent to 5 g” instead of “each bottle contains: cephalexin monohydrate, USP equivalent to 10 g.” The product was manufactured by Alkem Laboratories Ltd. and relabeled by Bryant Ranch Prepack Inc., Burbank, California.
- cephalexin for oral suspension, 250 mg per 5 mL, 100 mL when mixed (NDC 63629-9206-1), from lots 235288, 235294, 235368, 235806, 236058, 236138, 236139, 236351, 236490, 236757, and 236877 (Exp.11/30/25), and 236758, 236762, 237254, 237349, 237401, and 237807 (Exp. 12/31/25). The product’s back label states “each contains: cephalexin monohydrate, USP equivalent to 5 g” instead of “each bottle contains: cephalexin monohydrate, USP equivalent to 5 g.” The product was manufactured by Alkem Laboratories Ltd. and relabeled by Bryant Ranch Prepack Inc., Burbank, California.
Bryant Ranch Prepack voluntarily initiated the recalls on May 10, 2024. On June 4, 2024, the FDA designated them Class III. Per the recall classification, use of the affected products is not likely to cause harm.
Cephalexin oral suspension is a prescription cephalosporin antibacterial drug with indications for respiratory tract infections, otitis media, skin infections, bone infections, and genitourinary tract infections.
