FDAFDA · Food and drugs·Recall number D-0075-2022
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. for: Advanced First Aid, Baltimore, MD 21237; American Safety & First Aid, Osceola, IN 46561 (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 #: AK-9457, exp. date 22-Jan; AK-9521, exp. date 22-Mar; AK-9959, exp. date 22-Dec; AK-1017, exp. date 23-Jan
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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