SUN PHARMACEUTICAL INDUSTRIES INC Recall: Zolpidem Tartrate Extended-Release Tablets, USP
SUN PHARMACEUTICAL INDUSTRIES INC Recall: Zolpidem Tartrate Extended-Release Tablets, USP is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC; Product: Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by:
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC |
|---|---|
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Completed |
| Distribution | Nationwide in the USA |
| Recall initiated | 20240118 |
| Recall number | D-0272-2024 |
| Category | drug |
| State | NJ |
| Country | United States |
$29/mo
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