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Class III · Lower riskRecall completed

Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #: AK8745, Exp. Date 08/20; AK9751, Exp. Date 08/2021; AK9552, Exp. Date 04/2022
Where it was soldProduct was shipped to two distributors in IL and TX who may have further repackaged and distributed the product.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forSelect Corporation, Carrollton, TX 75007
Show the full FDA record
Full product labelPain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufactured for Select Corporation, Carrollton, TX 75007
Recalling firmUltra Seal Corporation
DistributionProduct was shipped to two distributors in IL and TX who may have further repackaged and distributed the product.
Quantity4,666,355 packets
Recall initiated2020-08-03
Report date2020-08-26
Recall completed2021-03-16
Recall numberD-1512-2020
ClassificationClass III
FDA statusTerminated
Origin on fileNew Paltz NY United States

Related

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.