PAIN AID ESF- coated recalled over manufacturing violations

Recall date

November 29, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

ULTRAtab Laboratories, Inc. recalls PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated…

Recall number

D-0327-2022

FDA classification

Class II

Brand / firm

ULTRAtab Laboratories, Inc.

Sold / distributed

Product was distributed to one customer who may have further distributed the product.

Why it was recalled

CGMP Deviations: failed stability results, inadequate laboratory investigations,

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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