Home / Recalls / Ultra Seal Corporation / D-0077-2022

D-0077-2022 Class III Terminated

Recalled by Ultra Seal Corporation — New Paltz, NY

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

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