PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets ...
FDA Recall #D-0327-2022 — Class II — November 29, 2021
Product Description
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
Reason for Recall
CGMP Deviations: failed stability results, inadequate laboratory investigations,
Recalling Firm
ULTRAtab Laboratories, Inc. — Highland, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
14 bulk lots (approximately 1,987,951 tablets each)
Distribution
Product was distributed to one customer who may have further distributed the product.
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.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated