ULTRAtab Laboratories, Inc.: Drug Recall
Recall #D-0524-2022 · 01/26/2022
Class II: Risk
Recall Details
- Recall Number
- D-0524-2022
- 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
- 19,103,287 tablets
Reason for Recall
CGMP Deviations
Product Description
4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-107-00
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.