Recalls / Class II
Class IID-0327-2022
Product
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
- Affected lot / code info
- 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.
Why it was recalled
CGMP Deviations: failed stability results, inadequate laboratory investigations,
Recalling firm
- Firm
- ULTRAtab Laboratories, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 50 Toc Dr, N/A, Highland, New York 12528-1506
Distribution
- Quantity
- 14 bulk lots (approximately 1,987,951 tablets each)
- Distribution pattern
- Product was distributed to one customer who may have further distributed the product.
Timeline
- Recall initiated
- 2021-11-29
- FDA classified
- 2022-01-04
- Posted by FDA
- 2022-01-12
- Terminated
- 2023-02-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0327-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.