Recalls / Class II
Class IID-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.
- Brand name
- Lurasidone Hydrochloride
- Generic name
- Lurasidone Hydrochloride
- Active ingredient
- Lurasidone Hydrochloride
- Route
- Oral
- NDCs
- 47335-578, 47335-684, 47335-639, 47335-685, 47335-579
- FDA application
- ANDA208066
- Affected lot / code info
- Lot #s: DNE0621A Exp. 11/30/2024, DNE0815A Exp. 12/31/2024
Why it was recalled
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 9,408 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-01-18
- FDA classified
- 2024-01-25
- Posted by FDA
- 2024-01-31
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0267-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.