FDAFDA · Food and drugs·Recall number D-1512-2020
Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufactured for Select Corporation, Carrollton, TX 75007
Published August 26, 2020 · Recall initiated: August 3, 2020
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 (OOS) results for the Aspirin related compound Salicylic Acid was observed.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ultra Seal Corporation
- Distributor
- Product was shipped to two distributors in IL and TX who may have further repackaged and distributed the product.
- Lot
- Lot #: AK8745, Exp. Date 08/20; AK9751, Exp. Date 08/2021; AK9552, Exp. Date 04/2022
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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