Apotex Recalls Cevimeline Hydrochloride Capsules Due to Stability Failures
Apotex Inc. is recalling Cevimeline Hydrochloride Capsules, 30 mg, because the product may not meet specification limits for assay testing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential failure to meet assay specifications without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Apotex Inc. is recalling Cevimeline Hydrochloride Capsules, 30 mg, in 100-count and 500-count bottles. The recall involves 117,644 bottles distributed nationwide and in Puerto Rico. The product is manufactured by Apotex Research Pvt., Ltd., Bangalore, India, for Apotex Corp, Westin, FL.
The recall was initiated because the product failed stability specifications and may not meet the specification limit for the assay test. This indicates that the amount of active ingredient in the capsules may not be consistent with the required standard.
Consumers and healthcare providers should stop using the affected lots and return them to the pharmacy or point of purchase. The affected lot numbers are KP9749, KT3501, KP4524, KX8713, KX8714, KX8715, KP4525, KP9750, and KX8716, with expiration dates ranging from September 2015 to April 2016.
The recalled product
- 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
- Manufacturer
- Apotex Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 117,644
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- Lot #s: a) KP9749
- KT3501
- Exp 09/2015
- KP4524
- Exp 11/2015
- KV8264
- Exp 01/2016
- KX8713
- KX8714
- KX8715
- Exp 04/2016
- b) KP4525
- KP9750
- Exp 12/2015
- KX8716
Distribution
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