FDARecalled Dec 11, 2024 · #D-0079-2025
Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hi...
Hazard
Class II — temporary health risk
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cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit Classification: Class II Distribution: USA Nationwide
Product details
- Product
- Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. 90 mg - 30 Tablets - NDC 65862-833-30 90 mg - 500 Tablets - NDC 65862-833-05
- Type
- Drugs
- Manufacturer
- Aurobindo Pharma USA Inc
- Model numbers
- —
- UPCs
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