Why it was recalled
Failed Stability Specifications: product may not meet specification limit for assay test.
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1814-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 17, 2015
- FDA report date
- Sep 23, 2015
- Quantity
- 117,644 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Inc.
Original FDA data
Every field from FDA enforcement report D-1814-2015, exactly as published.
Show all FDA fields
- City
- Toronto
- Status
- Terminated
- Country
- Canada
- Event ID
- 71999
- Address
- 150 Signet Drive
- Code information
- 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
- Report date
- Sep 23, 2015
- Product type
- Drugs
- Recall number
- D-1814-2015
- Classification
- Class II
- Recalling firm
- Apotex Inc.
- Product quantity
- 117,644 Bottles
- Termination date
- Jun 15, 2022
- Reason for recall
- Failed Stability Specifications: product may not meet specification limit for assay test.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Aug 17, 2015
- Center classification date
- Sep 15, 2015