Class II · Moderate risk
Scopolamine Hydrobromide 0.25% Oph Solution
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Scopolamine Transdermal Therapeutic System (Scopolamine Transdermal System)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Defective delivery system
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
Scopolamine Transdermal Therapeutic System, 1 mg/3 days, a) 4-count (NDC 45802-580-84); b) 10-count (NDC 45802-580-46); c) 24-count (NDC 45802-580-62), Rx only, Mfd. by: Aveva Drug Delivery Systems, A Nitto Denko Company, Miramar, FL 33025 Distributed by Perrigo, Allegan, MI 49010
Affected NDCs
45802-0580-46
45802-0580-62
45802-0580-84
Compare with the code on your package — it is the most precise check available.
Drug: Scopolamine
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 |
|---|---|---|---|---|
| Scopolamine Transdermal System NDC 45802-0580 |
SCOPOLAMINE 1 mg/1 | Patch, Extended Release Transdermal |
Padagis Israel Pharmaceuticals Ltd | Rx |
- Recalling firm
- L. Perrigo Company
- NDC code
- 45802-580-84
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0816-2018 · 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 terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Scopolamine recalls
See all
Class II · Moderate risk
Transderm Scop
cGMP deviations: Temperature abuse
Class II · Moderate risk
Transderm Scop
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.
Class II · Moderate risk
Transderm Scop
Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.
Class III · Low risk
Donnatal
Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.
Other recalls by L. Perrigo Company
All 2018 recalls
Class II · Moderate risk
Allergy Relief
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Picnic
Failed Impurities/Degradation Specifications
Class II · Moderate risk
allergy relief
Failed Impurities/Degradation Specifications
Class II · Moderate risk
allergyrelief
Failed Impurities/Degradation Specifications
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