Apotex Inc. recalls Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count bottle, Rx Only, Manufactured by: Apotex…

Recall date

August 17, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1814-2015

FDA classification

Class II

Brand / firm

Apotex Inc.

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

Failed Stability Specifications: product may not meet specification limit for assay test.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count bottle, Rx Only, Manufactured by: Apotex Research Pvt., Ltd., Bangalore, India, Manufactured for: Apotex Corp, Westin, FL, a) NDC 60505-3145-1, b) NDC 60505-3145-5