Class II · Moderate risk Terminated
Scopolamine Hydrobromide 0.25% Oph Solution
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Scopolamine 0.25 opth.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
What was recalled
Scopolamine 0.25 opth.
- Recalling firm
- Natures Pharmacy & Compounding Center
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1132-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Scopolamine recalls
See all
Class II · Moderate risk Terminated
Transderm Scop
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Scopolamine Transdermal Therapeutic System
Reason Defective delivery system
Class II · Moderate risk Terminated
Transderm Scop
Reason 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 Terminated
Transderm Scop
Reason Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.
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