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FDANovember 29, 2021drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

CGMP Deviations: failed stability results, inadequate laboratory investigations,

What to do

FDA enforcement status: Terminated

Brands named

ultratab laboratoriesultratab

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 — Recall Details · AllClear