Drug recall D-0263-2024
Product
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.
Reason for recall
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Lots and codes
Lot #: DNE0702A, Exp. 06/30/2026
Recall details
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
- Quantity
- 1,728 bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 18, 2024
Related products
- Cinacalcet – drug information
- NDC 47335-600 Cinacalcet · Cinacalcet Hydrochloride 90 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 47335-379 Cinacalcet · Cinacalcet Hydrochloride 30 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 47335-380 Cinacalcet · Cinacalcet Hydrochloride 60 mg/1 · Sun Pharmaceutical Industries, Inc.