ULTRAtab Laboratories, Inc. recalls Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Laboratories, I
Recalled February 16, 2022 · FDA recall D-0525-2022 · ULTRAtab Laboratories
Hazard
CGMP Deviations · FDA Class II
Units
1,798,048 tablets
Sold at
Bulk product was distributed to 3 distributors who may have distributed finished product.
Description
CGMP Deviations
Product
Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-111-xx
Manufacturer(s)
ULTRAtab Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →