Scopolamine 1 mg/3d
scopolamine · PATCH · A-S Medication Solutions
Scopolamine is a patch containing scopolamine at 1 mg/3d, taken transdermal. Manufactured by A-S Medication Solutions.
Key Facts
- Brand Name
- Scopolamine
- Generic Name
- scopolamine
- NDC Code (Product)
50090-5349- Manufacturer
- A-S Medication Solutions
- Strength
- 1 mg/3d
- Dosage Form
- PATCH
- Route
- TRANSDERMAL
- Marketing Status
- Application #
- ANDA203753
- Drug Class
- Anticholinergic [EPC]
- Marketing Start
- 06/19/2019
Recall History
Natures Pharmacy & Compounding Center
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Physicians Total Care, Inc.
Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall.
Pharmacy Innovations
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Sandoz Inc
Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.
Sandoz Inc
Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stating "Do cut the patch" rather than the correct instructions of "Do not cut the patch". The pouch containing the patch is labeled correctly.
West-ward Pharmaceutical Corp.
Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.
Safecor Health, LLC
Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.
Aidapak Services, LLC
Labeling:Label Mixup; PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 mg/0.0194 mg/0.0065 mg may be potentially mislabeled as VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: W003639, EXP: 6/25/2014.
L. Perrigo Company
Defective delivery system
Rx PAK
Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Full prescribing information not available for this product.
Frequently Asked Questions
What is Scopolamine used for?
Scopolamine contains scopolamine. It is a patch taken transdermal. Consult your doctor for specific uses.
Is Scopolamine a controlled substance?
Scopolamine is not classified as a controlled substance by the DEA.
What is the generic name for Scopolamine?
The generic name for Scopolamine is scopolamine. There are 2 other brand versions of scopolamine.
What is the NDC code for Scopolamine 1 mg/3d?
The NDC (National Drug Code) for Scopolamine 1 mg/3d is 50090-5349, listed by A-S Medication Solutions.