Class II · Moderate risk
Zolpidem Tartrate Extended-Release Tablets
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Zolpidem Tartrate Extended-Release Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
What was recalled
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.
Affected NDC
47335-0307-88
Compare with the code on your package — it is the most precise check available.
Drug: Zolpidem
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Zolpidem Tartrate NDC 47335-0307 |
6.25 mg/1 | Tablet, Film Coated, Extended Release Oral |
Sun Pharmaceutical Industries, Inc. | Rx · CIV |
- Recalling firm
- Sun Pharmaceutical Industries INC
- NDC code
- 47335-307-88
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0271-2024 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now completed, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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Class II · Moderate risk
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CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk
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Class III · Low risk
Intermezzo
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Class II · Moderate risk
Zolpidem Tartrate Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
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