Drug recall D-0267-2024
Product
Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-579-83.
Reason for recall
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Lots and codes
Lot #s: DNE0621A Exp. 11/30/2024, DNE0815A Exp. 12/31/2024
Recall details
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
- Quantity
- 9,408 bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 18, 2024
Related products
- Lurasidone hydrochloride – drug information
- NDC 47335-685 Lurasidone Hydrochloride · Lurasidone Hydrochloride 80 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 47335-579 Lurasidone Hydrochloride · Lurasidone Hydrochloride 120 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 47335-578 Lurasidone Hydrochloride · Lurasidone Hydrochloride 20 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 47335-684 Lurasidone Hydrochloride · Lurasidone Hydrochloride 40 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 47335-639 Lurasidone Hydrochloride · Lurasidone Hydrochloride 60 mg/1 · Sun Pharmaceutical Industries, Inc.