D-0525-2022 Class II Terminated
FDA drug recall D-0525-2022 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: 1,798,048 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
- 1,798,048 tablets
Product Description
Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-111-xx
Reason for Recall
CGMP Deviations
Distribution Pattern
Bulk product was distributed to 3 distributors who may have distributed finished product.
Code Information
Product Codes: C111L Bulk Lot: 18L028