Reported Nov 3, 2021 · Terminated
Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet,…
Ultra Seal Corporation
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ultra Seal Corporation · 521 Main St · New Paltz, NY · 12561-1609
Is this the product you have?
- Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Packets/Case, PO# 007564-00, Item# 1170, Mfg
- forAdvanced First Aid, Baltimore, MD 21237; American Safety & First Aid, Osceola, IN 46561 (Shipping Label)
- Lot codes and dates
Lot #: AK-9457exp. date 22-JanAK-9521exp. date 22-MarAK-9959exp. date 22-DecAK-1017exp. date 23-Jan
- Amount recalled
- 991,310 tablets
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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