Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC…
Reason CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
9 FDA recalls mention Mirtazapine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Mirtazapine.
Reason CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Reason Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg…
Reason Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg…
Reason Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled
Reason Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle
Reason Lack of Processing Controls
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Labeling:Label Mixup; MIRTAZAPINE Tablet, 7.5 mg may be potentially mislabeled as ISONIAZID, Tablet, 300 mg, NDC 00555007102, Pedigree: W003691…
Reason Labeling:Label Mixup; MIRTAZAPINE Tablet, 7.5 mg may be potentially mislabeled as BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, NDC 00574010603…
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