Ultra Seal Corporation: Drug Recall
Recall #D-0499-2022 · 01/24/2022
Class II: Risk
Recall Details
- Recall Number
- D-0499-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Ultra Seal Corporation
- Status
- Terminated
- Date Initiated
- 01/24/2022
- Location
- New Paltz, NY, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 533,100 packets
Reason for Recall
cGMP deviations
Product Description
PAPENOL (acetaminophen 500 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423
Distribution Pattern
Nationwide within the United States
Other Recalls by Ultra Seal Corporation
- Class II: Risk 01/24/2022
- Class II: Risk 01/24/2022
- Class II: Risk 01/24/2022
- Class II: Risk 01/24/2022
- Class II: Risk 01/24/2022
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.