Ultra Seal Corporation: Drug Recall
Recall #D-0076-2022 · 10/13/2021
Class III: Low Risk
Recall Details
- Recall Number
- D-0076-2022
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- Ultra Seal Corporation
- Status
- Terminated
- Date Initiated
- 10/13/2021
- Location
- New Paltz, NY, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42,394,018 tablets
Reason for Recall
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Product Description
Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, Material# 111519, Mfg. for: Cintas First Aid & Safety, Mason, OH 45040 (Shipping Label)
Distribution Pattern
Nationwide in the USA.
Other Recalls by Ultra Seal Corporation
- Class II: Risk 01/24/2022
- Class II: Risk 01/24/2022
- Class II: Risk 01/24/2022
- Class II: Risk 01/24/2022
- Class II: Risk 01/24/2022
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.