Recalls / Class II

Class IID-0271-2024

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.

Brand name: Zolpidem Tartrate
Generic name: Zolpidem Tartrate
Active ingredient: Zolpidem Tartrate
Route: Oral
NDCs: 47335-307, 47335-308
FDA application: ANDA204170
Affected lot / code info: Lot #: DNE0892A Exp. 07/31/2026

Why it was recalled

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Recalling firm

Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Manufacturer: Sun Pharmaceutical Industries, Inc.
Notification channel: Letter
Type: Voluntary: Firm initiated
Address: 2 Independence Way, N/A, Princeton, New Jersey 08540-6620

Distribution

Quantity: 1220 bottles
Distribution pattern: Nationwide in the USA

Timeline

Recall initiated: 2024-01-18
FDA classified: 2024-01-25
Posted by FDA: 2024-01-31
Status: Completed

Source: openFDA Drug Enforcement endpoint. Recall record D-0271-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.