D-0072-2022 Class III Terminated

Recalled by Ultra Seal Corporation — New Paltz, NY

Recall Details

Product Type
Drugs
Report Date
November 3, 2021
Initiation Date
October 13, 2021
Termination Date
March 28, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,968,150 tablets

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.

Distribution Pattern

Nationwide in the USA.

Code Information

Lot #: AK-9547, exp. date 22- Apr; AK-9941, exp. date 22-Dec