Zolpidem Tartrate Extended-Release Tablets recall: CGMP Deviations
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.
Why was Zolpidem Tartrate Extended-Release Tablets recalled?
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: DNE0893A Expires 07/31/2026
- 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.
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Quantity
- 14,568 bottles
- Distribution
- Nationwide in the USA
- Recall date
- January 31, 2024
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (drug)