Natures Pharmacy Recalls 5-Fluorouracil Eye Drops for Sterility Concerns
Natures Pharmacy & Compounding Center is recalling 5-Fluorouracil eye drops due to quality control issues that may affect 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant risks such as sterility assurance failures in sterile products are categorized as Severe.
Plain-English summary
Natures Pharmacy & Compounding Center is recalling all lots of 5-Fluorouracil pf in methocel 1% opthal that are not expired. The recall is limited to North Carolina (NC).
The recall was initiated due to a lack of sterility assurance. This was identified during a recent FDA inspection, which observed quality control procedures that present a potential risk to the sterility of the compounded sterile products.
Consumers should stop using the recalled eye drops and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- 5-Fluorouracil pf in methocel 1% opthal
- 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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