D-0553-2022 Class II Terminated
FDA drug recall D-0553-2022 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: 25,769,495 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
- 25,769,495 tablets
Product Description
Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-800-00
Reason for Recall
CGMP Deviations
Distribution Pattern
Bulk product was distributed to 3 distributors who may have distributed finished product.
Code Information
Product Codes: M800L Bulk Lots: 18K005, 18K075, 18K098, 18M064, 19C021, 19C050, 19G081, 19G082, 19H012, 19H013, 19J036, 19J037