D-0548-2022 Class II Terminated
FDA drug recall D-0548-2022 was initiated by ULTRAtab Laboratories, Inc. on Jan 26, 2022 and is designated Class II. Reason for recall: CGMP Deviations The recall status is terminated (terminated Jan 7, 2025). Affected quantity: 6,380,282 tablets.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 16, 2022
- Initiation Date
- Jan 26, 2022
- Termination Date
- Jan 7, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,380,282 tablets
Product Description
APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-700-00
Reason for Recall
CGMP Deviations
Distribution Pattern
Bulk product was distributed to 3 distributors who may have distributed finished product.
Code Information
Product Codes: M700LA Bulk Lots: 18K037, 18L093, 18M006, 19A121, 19G044, 19G045, 19G046
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0548-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026