ULTRAtab Laboratories, Inc. recalls Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY ND
Recalled February 16, 2022 · FDA recall D-0552-2022 · ULTRAtab Laboratories
Hazard
CGMP Deviations · FDA Class II
Units
14,066,434 tablets
Sold at
Bulk product was distributed to 3 distributors who may have distributed finished product.
Description
CGMP Deviations
Product
Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-785-00
Manufacturer(s)
ULTRAtab Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →