FDAFDA · Food and drugs·Recall number D-0267-2024
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.
Published January 31, 2024 · Recall initiated: January 18, 2024
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- LURASIDONE HYDROCHLORIDE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Distributor
- Nationwide in the USA
- Lot
- Lot #s: DNE0621A Exp. 11/30/2024, DNE0815A Exp. 12/31/2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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