D-0528-2022 Class II Terminated
FDA drug recall D-0528-2022 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: 14,566,510 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
- 14,566,510 tablets
Product Description
Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-134-00
Reason for Recall
CGMP Deviations
Distribution Pattern
Bulk product was distributed to 3 distributors who may have distributed finished product.
Code Information
Product Codes: C134LC Bulk Lots: 18K055 18M081 19A097 19B024 19C054 19E092 19G094 19J042
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0528-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026