FDA Drug Moderate Class II Terminated

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

Reported: January 12, 2022 Initiated: November 29, 2021 #D-0327-2022

Product Description

Reason for Recall

CGMP Deviations: failed stability results, inadequate laboratory investigations,

Details

Recalling Firm: ULTRAtab Laboratories, Inc.
Units Affected: 14 bulk lots (approximately 1,987,951 tablets each)
Distribution: Product was distributed to one customer who may have further distributed the product.
Location: Highland, NY

Frequently Asked Questions

What product 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. Recalled by ULTRAtab Laboratories, Inc.. Units affected: 14 bulk lots (approximately 1,987,951 tablets each).

Why was this product recalled? ▼

CGMP Deviations: failed stability results, inadequate laboratory investigations,

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on January 12, 2022. Severity: Moderate. Recall number: D-0327-2022.