PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case, Material # 11161, Mfg. for Respond Industries First Aid, Mason, OH 45040 (Shipping Label)
Reported: November 3, 2021 Initiated: October 13, 2021 #D-0070-2022
Product Description
PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case, Material # 11161, Mfg. for Respond Industries First Aid, Mason, OH 45040 (Shipping Label)
Reason for Recall
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Details
- Recalling Firm
- Ultra Seal Corporation
- Units Affected
- 2,484,274 tablets
- Distribution
- Nationwide in the USA.
- Location
- New Paltz, NY
Frequently Asked Questions
What product was recalled? ▼
PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case, Material # 11161, Mfg. for Respond Industries First Aid, Mason, OH 45040 (Shipping Label). Recalled by Ultra Seal Corporation. Units affected: 2,484,274 tablets.
Why was this product recalled? ▼
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 3, 2021. Severity: Low. Recall number: D-0070-2022.
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