Class III
Terminated
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)
This recall has been terminated (originally issued November 3, 2021).
- Company
- Ultra Seal Corporation
- Recall Initiated
- October 13, 2021
- Posted
- November 3, 2021
- Recall Number
- D-0077-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 519,600 tablets
- Firm Location
- New Paltz, NY, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Distribution
Nationwide in the USA.
Lot / Code Info
Lot #: 9819, K-9819, exp. date 22-Sep
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