ULTRAtab Laboratories, Inc. recalls APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container, ULTRAtab Laboratories, I
Recalled February 16, 2022 · FDA recall D-0530-2022 · ULTRAtab Laboratories
Hazard
CGMP Deviations · FDA Class II
Units
14,349,148 tablets
Sold at
Bulk product was distributed to 3 distributors who may have distributed finished product.
Description
CGMP Deviations
Product
APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-140-00
Manufacturer(s)
ULTRAtab Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →