ULTRAtab Laboratories, Inc.: Drug Recall
Recall #D-0327-2022 · 11/29/2021
Class II: Risk
Recall Details
- Recall Number
- D-0327-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Status
- Terminated
- Date Initiated
- 11/29/2021
- Location
- Highland, NY, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 bulk lots (approximately 1,987,951 tablets each)
Reason for Recall
CGMP Deviations: failed stability results, inadequate laboratory investigations,
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
Distribution Pattern
Product was distributed to one customer who may have further distributed the product.
Other Recalls by ULTRAtab Laboratories, Inc.
- Class II: Risk 01/26/2022
- Class II: Risk 01/26/2022
- Class II: Risk 01/26/2022
- Class II: Risk 01/26/2022
- Class II: Risk 01/26/2022
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.