ULTRAtab Laboratories, Inc. recalls APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-210-00
Recalled February 16, 2022 · FDA recall D-0536-2022 · ULTRAtab Laboratories
Hazard
CGMP Deviations · FDA Class II
Units
6,249,082 tablets
Sold at
Bulk product was distributed to 3 distributors who may have distributed finished product.
Description
CGMP Deviations
Product
APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-210-00
Manufacturer(s)
ULTRAtab Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →