PlainRecalls
FDA Drug Low Class III Terminated

ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Tablets per/package, Packaged in a) 50-count packages/carton, b) 125-count packages/carton, PA-ESF 1414Z, Dist. by: Zee Medical Distributors, LLC Mason, OH 45040 (Shipping Label)

Reported: November 3, 2021 Initiated: October 13, 2021 #D-0072-2022

Product Description

ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Tablets per/package, Packaged in a) 50-count packages/carton, b) 125-count packages/carton, PA-ESF 1414Z, Dist. by: Zee Medical Distributors, LLC 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
1,968,150 tablets
Distribution
Nationwide in the USA.
Location
New Paltz, NY

Frequently Asked Questions

What product was recalled?
ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Tablets per/package, Packaged in a) 50-count packages/carton, b) 125-count packages/carton, PA-ESF 1414Z, Dist. by: Zee Medical Distributors, LLC Mason, OH 45040 (Shipping Label). Recalled by Ultra Seal Corporation. Units affected: 1,968,150 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-0072-2022.