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Class II · ModerateRecall completed

PAIN TERMINATOR extra strength pain relief (aspirin 162 mg

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: AK9451, Exp. Date 01/2022
Where it was soldNationwide within the United States
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

cGMP deviations

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 / forTellus Medical Products, Palm Desert, CA 92211
NDC69103-2507
Show the full FDA record
Full product labelPAIN TERMINATOR extra strength pain relief (aspirin 162 mg, acetaminophen 110 mg, Caffeine 32.4mg, Salicylamide 152 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2507
Recalling firmUltra Seal Corporation
DistributionNationwide within the United States
Quantity1,188,280 packets
Recall initiated2022-01-24
Report date2022-02-09
Recall completed2023-10-16
Recall numberD-0488-2022
ClassificationClass II
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.