Reported Nov 3, 2021 · Terminated
AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets Per Packet, Packaged in…
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?
- AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets Per Packet, Packaged in 10,000 Packets/Case, PO# 11938, Mfg
- forAero Healthcare, Valley Cottage, NY 10989 (Shipping Label )
- Lot codes and dates
Lot #: K-1278exp. date 23-JulK-9371AK-9463exp. date 21-NovAK-9821AK-9819exp. date 22-Sep1107exp. date 23-Mar
- Amount recalled
- 1,480,981 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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