Aurobindo Pharma USA Inc Recall: Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE
Aurobindo Pharma USA Inc Recall: Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Aurobindo Pharma USA Inc; Product: Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC
| Recalling firm | Aurobindo Pharma USA Inc |
|---|---|
| Product | Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. |
| Reason for recall | cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | USA Nationwide |
| Recall initiated | 20241107 |
| Recall number | D-0077-2025 |
| Category | drug |
| State | NJ |
| Country | United States |
$29/mo
Try RecallGuard →