Reported Sep 23, 2015 · Terminated
Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count bottle, Rx Only, Manufactured by: Apotex…
Apotex Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Apotex Inc. · 150 Signet Drive · Toronto · N/A
Is this the product you have?
- Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count bottle, Rx Only
- Manufactured byApotex Research Pvt., Ltd., Bangalore, India
- Manufactured forApotex Corp, Westin, FL, a) NDC 60505-3145-1, b) NDC 60505-3145-5
- Lot codes and dates
Lot #s: a) KP9749KT3501Exp 09/2015KP4524Exp 11/2015KV8264Exp 01/2016KX8713KX8714KX8715Exp 04/2016b) KP4525Exp 11/2015KP9750Exp 12/2015KX8716Exp 04/2016
- Amount recalled
- 117,644 Bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Stability Specifications: product may not meet specification limit for assay test.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Apotex Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.