ULTRAtab Laboratories, Inc. recalls 4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL 5mg) Bulk
Recalled February 16, 2022 · FDA recall D-0524-2022 · ULTRAtab Laboratories
Hazard
CGMP Deviations · FDA Class II
Units
19,103,287 tablets
Sold at
Bulk product was distributed to 3 distributors who may have distributed finished product.
Description
CGMP Deviations
Product
4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-107-00
Manufacturer(s)
ULTRAtab Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →