Recall D-0327-2022
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
Recall D-0327-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0327-2022 |
| Event ID | 89214 |
| Distribution | Product was distributed to one customer who may have further distributed the product. |
| Quantity | 14 bulk lots (approximately 1,987,951 tablets each) |
| Recall Reason | CGMP Deviations: failed stability results, inadequate laboratory investigations, |
| Drug Classification | Class II |
| Drug Code Info | 20220112 |
| Recall Initiation Date | 20211129 |
| Report Date | 20220112 |
| Classification Date | 20220104 |
| Address | 50 Toc Dr Highland, NY 12528-1506 United States |
| Recalling Firm | ULTRAtab Laboratories, Inc. |
| Initial Notification | Letter |
| Similar To |