PlainRecalls
FDA Drug Moderate Class II Terminated

Meclizine HCl Tablets, USP, 12.5 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328, Product of India, NDC 52536-129-01

Reported: February 24, 2021 Initiated: February 4, 2021 #D-0258-2021

Product Description

Meclizine HCl Tablets, USP, 12.5 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328, Product of India, NDC 52536-129-01

Reason for Recall

Failed Dissolution Specifications

Details

Units Affected
2112 bottles
Distribution
FL, TX
Location
Atlanta, GA

Frequently Asked Questions

What product was recalled?
Meclizine HCl Tablets, USP, 12.5 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328, Product of India, NDC 52536-129-01. Recalled by Wilshire Pharmaceuticals Inc. Units affected: 2112 bottles.
Why was this product recalled?
Failed Dissolution Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on February 24, 2021. Severity: Moderate. Recall number: D-0258-2021.