Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc…
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-0272-2024
- Product quantity
- 14,568 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 #: DNE0893A Expires 07/31/2026
- Product description
Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 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 47335-308-88.
- Harmonized identifiers (openFDA)
- Application number
- ANDA204170
- Brand name
- ZOLPIDEM TARTRATE
- Generic name
- ZOLPIDEM TARTRATE
- Manufacturer name
- Sun Pharmaceutical Industries, Inc.
- Product NDC
- 47335-307, 47335-308
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- ZOLPIDEM TARTRATE
- RxCUI
- 854880, 854894
- SPL ID
- 4a5c474b-e752-4d01-be37-a66e7c9bf62e
- SPL set ID
- 0c64bc71-2e7f-4b15-a8e1-acb8de04395f
- Package NDC
- 47335-307-88, 47335-307-13, 47335-308-88, 47335-308-13
- Is original packager
- true
- Upc
- 0347335307887, 0347335308884
- UNII
- WY6W63843K