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
Reported: August 26, 2020 Initiated: August 3, 2020 #D-1512-2020
Product Description
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
Reason for Recall
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Details
- Recalling Firm
- Ultra Seal Corporation
- Units Affected
- 4,666,355 packets
- Distribution
- Product was shipped to two distributors in IL and TX who may have further repackaged and distributed the product.
- Location
- New Paltz, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Ultra Seal Corporation. Units affected: 4,666,355 packets.
Why was this product recalled? ▼
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 26, 2020. Severity: Low. Recall number: D-1512-2020.
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