Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactu…
SUN PHARMACEUTICAL INDUSTRIES INC · CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- Status
- Completed
- City
- Princeton
- State
- NJ
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 93820
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Address 1
- 2 Independence Way
- Address 2
- N/A
- Postal code
- 08540-6620
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
- Recall number
- D-0263-2024
- Product quantity
- 1,728 bottles
- Reason for recall
- CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- Recall initiation date
- 20240118
- Center classification date
- 20240125
- Report date
- 20240131
- Code info
- Lot #: DNE0702A, Exp. 06/30/2026
- Product description
Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), India, NDC 47335-380-83.
- Harmonized identifiers (openFDA)
- Application number
- ANDA207008
- Brand name
- CINACALCET
- Generic name
- CINACALCET
- Manufacturer name
- Sun Pharmaceutical Industries, Inc.
- Product NDC
- 47335-379, 47335-380, 47335-600
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- CINACALCET HYDROCHLORIDE
- RxCUI
- 432400, 432401, 432402
- SPL ID
- fb601aec-aba6-4bec-a98d-51e556fef95c
- SPL set ID
- 092553cf-1bcd-4c19-9adf-b46f2bda5c9e
- Package NDC
- 47335-379-83, 47335-380-83, 47335-600-83
- Is original packager
- true
- Upc
- 0347335600834
- UNII
- 1K860WSG25