Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08…
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-0266-2024
- Product quantity
- 11,400 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 #: DNE0620A Exp. 05/31/2025
- Product description
Lurasidone Hydrochloride Tablets 60mg, 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 47335-639-83.
- Harmonized identifiers (openFDA)
- Application number
- ANDA208066
- Brand name
- LURASIDONE HYDROCHLORIDE
- Generic name
- LURASIDONE HYDROCHLORIDE
- Manufacturer name
- Sun Pharmaceutical Industries, Inc.
- Product NDC
- 47335-578, 47335-684, 47335-639, 47335-685, 47335-579
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- LURASIDONE HYDROCHLORIDE
- RxCUI
- 1040031, 1040041, 1235247, 1297278, 1431235
- SPL ID
- 532e9d94-9135-b5cb-e063-6394a90a5f66
- SPL set ID
- 6d97d871-66d3-4ed8-bbc5-0620e9f69ae5
- Package NDC
- 47335-578-83, 47335-578-81, 47335-578-13, 47335-684-83, 47335-684-81, 47335-684-13, 47335-639-83, 47335-639-81, 47335-639-13, 47335-685-83, 47335-685-81, 47335-685-13, 47335-579-83, 47335-579-81, 47335-579-13
- Is original packager
- true
- UNII
- O0P4I5851I