FDAClass IIINovember 3, 2021

Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER recall

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)

Why was Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 9819, K-9819, exp. date 22-Sep

Product
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)
Recalling firm
Ultra Seal Corporation
Quantity
519,600 tablets
Distribution
Nationwide in the USA.
Recall date
November 3, 2021
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls