FDAFDA · Food and drugs·Recall number D-0073-2022
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. for: Aero Healthcare, Valley Cottage, NY 10989 (Shipping Label )
Published November 3, 2021 · Recall initiated: October 13, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ultra Seal Corporation
- Distributor
- Nationwide in the USA.
- Lot
- Lot #: K-1278, exp. date 23-Jul; K-9371, AK-9463, exp. date 21-Nov; AK-9821, AK-9819, exp. date 22-Sep; 1107, exp. date 23-Mar.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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