Class II · Moderate risk
Scopolamine Hydrobromide 0.25% Oph Solution
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Transderm Scop (Scopolamine)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP deviations: Temperature abuse
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
Transderm Scop (scopolamine) Transdermanl System, 1 mg/ 3 days, 10 (patches) transdermal Systems Multipack, Rx only, MFG: Baxter Healthcare Corp, NDC 10019-553-03
Affected NDC
10019-0553-03
Compare with the code on your package — it is the most precise check available.
Drug: Scopolamine
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- NDC code
- 10019-553-03
- Origin
- VA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1083-2022 · 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
Scopolamine Transdermal Therapeutic System
Defective delivery system
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 Mckesson Medical-Surgical Inc. Corporate Office
All 2022 recalls
Class II · Moderate risk
Infuvite Adult
Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
Class II · Moderate risk
Medroxyprogesterone Acetate Injectable Suspension
Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
Class II · Moderate risk
BENLYSTA (belimumab)
CGMP Deviations; potential temperature excursions due to transit delays
Class II · Moderate risk
Evenity
CGMP Deviations; potential temperature excursions due to transit delays
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