Drug product
Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, 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 47335-307-88.
D-0271-2024
Product summary
- Event
- Event 93820
- Status
- Completed
- Classification
- Class II
- Quantity
- 1220 bottles
- Official record key
drug-enforcement:D-0271-2024
Official wording
Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Code information: Lot #: DNE0892A Exp. 07/31/2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Microbial contamination
Microbial contamination