D-0552-2022 Class II Terminated
FDA drug recall D-0552-2022 was initiated by ULTRAtab Laboratories, Inc. on January 26, 2022 and is designated Class II. Reason for recall: CGMP Deviations The recall status is terminated (terminated January 7, 2025). Affected quantity: 14,066,434 tablets.
Recall Details
- Product Type
- Drugs
- Report Date
- February 16, 2022
- Initiation Date
- January 26, 2022
- Termination Date
- January 7, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,066,434 tablets
Product Description
Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-785-00
Reason for Recall
CGMP Deviations
Distribution Pattern
Bulk product was distributed to 3 distributors who may have distributed finished product.
Code Information
Product Codes: M785L Bulk Lots: 18K029, 18L059, 18M100, 19B013, 19D024, 19D059, 19E029, 19J050