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
Reported: September 23, 2015 Initiated: August 17, 2015 #D-1814-2015
Product Description
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.
Details
- Recalling Firm
- Apotex Inc.
- Units Affected
- 117,644 Bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Toronto
Frequently Asked Questions
What product 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. Recalled by Apotex Inc.. Units affected: 117,644 Bottles.
Why was this product recalled? ▼
Failed Stability Specifications: product may not meet specification limit for assay test.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 23, 2015. Severity: Moderate. Recall number: D-1814-2015.
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