Drug recall D-0272-2024
Product
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.
Reason for recall
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Lots and codes
Lot #: DNE0893A Expires 07/31/2026
Recall details
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
- Quantity
- 14,568 bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 18, 2024
Related products
- zolpidem tartrate – drug information
- NDC 47335-308 Zolpidem Tartrate · Zolpidem Tartrate 12.5 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 47335-307 Zolpidem Tartrate · Zolpidem Tartrate 6.25 mg/1 · Sun Pharmaceutical Industries, Inc.