D-0538-2022 Class II Terminated
FDA drug recall D-0538-2022 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: 50,585,623 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
- 50,585,623 tablets
Product Description
HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62969-242-00
Reason for Recall
CGMP Deviations
Distribution Pattern
Bulk product was distributed to 3 distributors who may have distributed finished product.
Code Information
Product Codes: L242SRC Bulk Lot: 18K086, 18L009, 18L050, 18L083, 18M025, 18M073, 18M098, 19A010, 19A084, 19A105, 19A107; Product Code: L242L Bulk Lot: 19H014; Product Code: L242PA Bulk Lot: 18F072, 18L119, 19A067, 19G043; Product Code: L242N Bulk Lot: 19H040