FDA recall D-1814-2015

Product

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

Reason for recall

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

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2015-08-17

Report date

2015-09-23

Termination date

2022-06-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Toronto, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1814-2015