D-0077-2022 Class III Terminated
FDA drug recall D-0077-2022 was initiated by Ultra Seal Corporation on October 13, 2021 and is designated Class III. Reason for recall: Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid. The recall status is terminated (terminated March 28, 2022). Affected quantity: 519,600 tablets.
Recall Details
- Product Type
- Drugs
- Report Date
- November 3, 2021
- Initiation Date
- October 13, 2021
- Termination Date
- March 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 519,600 tablets
Product Description
Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, PO# 19540, Mfg. for: Afassco Minden, NV 89423 (Shipping Label)
Reason for Recall
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot #: 9819, K-9819, exp. date 22-Sep