ULTRAtab Laboratories, Inc. recalls PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated
Recalled January 12, 2022 · FDA recall D-0327-2022 · ULTRAtab Laboratories
Hazard
CGMP Deviations: failed stability results, inadequate laboratory investigations, · FDA Class II
Units
14 bulk lots (approximately 1,987,951 tablets each)
Sold at
Product was distributed to one customer who may have further distributed the product.
Description
CGMP Deviations: failed stability results, inadequate laboratory investigations,
Product
PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated boxes lined with 2 polyethylene bags 100 lb, ULTRAtab Laboratories, Inc. NDC# 62959-560-00, Product Code M560L
Manufacturer(s)
ULTRAtab Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →