D-0327-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 12, 2022
- Initiation Date
- November 29, 2021
- Termination Date
- February 24, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 bulk lots (approximately 1,987,951 tablets each)
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,
Distribution Pattern
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.