Cinacalcet Tablets Recalled for Elevated Nitrosamine Impurity
AvKARE is recalling 2,396 bottles of Cinacalcet Tablets 60 mg (Lot #44550) distributed nationwide due to CGMP deviations. The tablets contain N-Nitroso-Cinacalcet, a nitrosamine impurity, above acceptable intake limits.
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 for pharmaceutical contamination (nitrosamine impurity) with no reported illnesses or injuries. Per the rubric, risk-of-harm products where injury has not been reported score at a maximum of High (3).
Plain-English summary
AvKARE is recalling Cinacalcet Tablets, 60 mg, in 30-count bottles. The affected lot is #44550, with an expiration date of 12/31/2024. A total of 2,396 bottles were distributed nationwide.
The recall is due to Current Good Manufacturing Practices (CGMP) deviations identified during manufacturing. Testing detected the presence of N-Nitroso-Cinacalcet, a nitrosamine impurity, at levels exceeding the acceptable intake limit.
Patients who possess this medication should contact their pharmacist or healthcare provider for guidance regarding this recall.
The recalled product
- Product
- Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30
- Manufacturer
- AvKARE
- Category
- Drug
- Hazard
- nitrosamine
- pharmaceutical-contamination
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 (2)
- Lot # 44550
- Exp 12/31/2024
Distribution
Distributed nationwide across the United States.
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