13 FDA recalls mention Scopolamine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Scopolamine.
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Reason cGMP deviations: Temperature abuse
Reason Defective delivery system
Reason Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stating "Do cut the patch" rather than the correct…
Reason Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.
Reason Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of…
Reason Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.
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 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 Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality…
Reason Labeling:Label Mixup; PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 mg/0.0194 mg/0.0065 mg may be potentially mislabeled…
Reason Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In…
Reason Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.
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