D-0512-2022 Class II Terminated
FDA drug recall D-0512-2022 was initiated by Ultra Seal Corporation on January 24, 2022 and is designated Class II. Reason for recall: cGMP deviations The recall status is terminated (terminated October 16, 2023). Affected quantity: 216,000 packets.
Recall Details
- Product Type
- Drugs
- Report Date
- February 9, 2022
- Initiation Date
- January 24, 2022
- Termination Date
- October 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 216,000 packets
Product Description
AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
Reason for Recall
cGMP deviations
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: AK9640, Exp. Date 03/2022