FDAHealthNovember 27, 2024
AvKARE — Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30
⚠️ CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 27, 2024
USA Nationwide
What's affected?
- Product
- Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30
- Brand
- AvKARE
- Lot code
- 44378
Additional details
Lot#: 44378, 44597, 45804, Exp 12/31/2024
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 50,304 bottles.
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