Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical…
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
10 FDA recalls mention Zolpidem. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Zolpidem.
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Failed Dissolution Specifications
Reason Failed dissolution specifications
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
Reason Labeling: Label Mixup; ZOLPIDEM TARTRATE Tablet, 2.5 mg (1/2 of 5 mg) may be potentially mislabeled as TEMAZEPAM, Capsule, 7.5 mg, NDC…
Reason Unit Dose Mispackaging: This recall event is due to a random undetected packaging issue which could increase the potential for a small number of…
Reason Adulterated Presence of Foreign Tablets: This product is being recalled becaiuse 30 valacyclovir hydrochloride tablets USP 500 mg were discovered in…
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