Class II
Completed
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.
- Recall Initiated
- January 18, 2024
- Posted
- January 31, 2024
- Recall Number
- D-0271-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1220 bottles
- Firm Location
- Princeton, NJ, United States
Reason for Recall
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Distribution
Nationwide in the USA
Lot / Code Info
Lot #: DNE0892A Exp. 07/31/2026
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