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

FDA recall notice · announced January 12, 2022 · Ultratab Laboratories

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

CGMP Deviations: failed stability results, inadequate laboratory investigations,

Notes

Distribution: Product was distributed to one customer who may have further distributed the product.
Lot/code information: Bulk Lots: 18K070, exp. date Nov-21; 19A046, exp. date Jan-22; 19C073, exp. date Mar-22; 19E014, exp. date May-22; 19G039, exp. date Jul-22; 19K002, exp. date Nov-22; 20A013, exp. date Jan-23; 20B050, exp. date Feb-23; 20C011, exp. date Mar-23; 20C049, exp. date Mar-23; 20F071, exp. date Jun-23; 20F072, exp. date Jun-23; 20G033, exp. date Jul-23; 20G041, exp. date Jul-23.
Quantity: 14 bulk lots (approximately 1,987,951 tablets each)
Status: Terminated
Products in this recall event:
- 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# 62 (D-0327-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.