Recall of 5-Fluorouracil 1% Ophthalmic Solution Due to Sterility Concerns
Natures Pharmacy & Compounding Center is recalling 5-Fluorouracil 1% ophthalmic solution due to quality control issues affecting sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or health risk potential.
Plain-English summary
Natures Pharmacy & Compounding Center is recalling all lots of 5-Fluorouracil 1% ophthalmic solution that are not expired. The recall is limited to products distributed in North Carolina.
The recall was initiated 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.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for instructions on how to dispose of or return the medication.
The recalled product
- Product
- 5-Fluorouracil 1% ophthal
- Manufacturer
- Natures Pharmacy & Compounding Center
- Category
- Drug — Ophthalmic
- Hazard
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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