FDA recall D-0258-2021

Wilshire Pharmaceuticals Inc · Class II · drug

Product

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

Distribution

FL, TX

Key facts

Status
Terminated
Initiation date
2021-02-04
Report date
2021-02-24
Termination date
2023-06-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Atlanta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0258-2021