Scopolamine 0.25 Ophthalmic Drops Recalled for Sterility Assurance Concerns
Natures Pharmacy & Compounding Center is recalling all unexpired lots of Scopolamine 0.25 ophthalmic drops due to quality control issues affecting sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. According to the rubric, an FDA Class II recall with potential for significant injury (loss of sterility in ophthalmic products) maps to a score of 4 (Severe), as it exceeds the threshold for 'High' which is typically for theoretical risks without reported illness or specific high-risk pathogens, and the loss of sterility assurance in eye drops poses a direct risk of serious infection.
Plain-English summary
Natures Pharmacy & Compounding Center is recalling all unexpired lots of Scopolamine 0.25 ophthalmic drops. The recall is being conducted due to concerns regarding quality control procedures that present a potential risk to sterility assurance. These concerns were identified during a recent FDA inspection of the pharmacy.
The recall includes all lots of sterile products compounded by the pharmacy that have not yet expired. The source text does not specify a particular distribution region, listing only the state code 'NC' in the structured data, but the recall notice itself refers to 'All lots' within the expiry period.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions. The FDA classifies this as a Class II recall, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Scopolamine 0.25 opth.
- Manufacturer
- Natures Pharmacy & Compounding Center
- Category
- Drug — Ophthalmic
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lot numbers within expiry.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 48 recalled by Natures Pharmacy & Compounding Center under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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