FDAFDA · Food and drugs·Recall number D-1814-2015
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
Published September 23, 2015 · Recall initiated: August 17, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Stability Specifications: product may not meet specification limit for assay test.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Apotex Inc.
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot #s: a) KP9749, KT3501, Exp 09/2015, KP4524, Exp 11/2015, KV8264, Exp 01/2016, KX8713, KX8714, KX8715, Exp 04/2016; b) KP4525, Exp 11/2015, KP9750, Exp 12/2015, KX8716, Exp 04/2016
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- Canada
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.