Drug & medication recalls

Ultra Seal Corporation recalls Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets…

Recall date
October 13, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0077-2022
FDA classification
Class III
Brand / firm
Ultra Seal Corporation
Sold / distributed
Nationwide in the USA.

Why it was recalled

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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)

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