Cinacalcet Tablets Recalled for Excess Nitrosamine Impurity
AvKARE is recalling Cinacalcet Tablets 30 mg due to nitrosamine impurity levels exceeding safe limits. Affected bottles nationwide should not be used.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The nitrosamine impurity exceeds acceptable levels but poses a theoretical risk without any documented harm, meeting the criteria for High (3) severity.
Plain-English summary
AvKARE is recalling Cinacalcet Tablets 30 mg (NDC 42291-459-30) distributed nationwide. The affected product is supplied in 30-count bottles manufactured for AvKARE in Pulaski, Tennessee.
The recall addresses a manufacturing deviation: the presence of N-nitroso-cinacalcet, a nitrosamine drug substance related impurity (NDSRI), at levels exceeding acceptable intake limits.
Affected bottles include lot numbers 44378, 44597, and 45804, with expiration date 12/31/2024. Approximately 50,304 bottles have been distributed. Consumers in possession of affected batches should consult their healthcare provider or pharmacist regarding this recall.
The recalled product
- Product
- Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30
- Manufacturer
- AvKARE
- Category
- Drug
- Hazard
- nitrosamine-impurity
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 (4)
- Lot#: 44378
- 44597
- 45804
- Exp 12/31/2024
Distribution
Distributed nationwide across the United States.
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