ULTRAtab Laboratories, Inc.: Drug Recall
Recall #D-0538-2022 · 01/26/2022
Class II: Risk
Recall Details
- Recall Number
- D-0538-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- ULTRAtab Laboratories, Inc.
- Status
- Terminated
- Date Initiated
- 01/26/2022
- Location
- Highland, NY, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50,585,623 tablets
Reason for Recall
CGMP Deviations
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
Distribution Pattern
Bulk product was distributed to 3 distributors who may have distributed finished 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.