Natures Pharmacy Recalls Dexamethosone/Tobramycin Ophthalmic Drops for Sterility Concerns
Natures Pharmacy & Compounding Center is recalling all unexpired lots of Dexamethosone/Tobramycin 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 classified this as an FDA Class II recall. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant risks such as sterility assurance failures in sterile products.
Plain-English summary
Natures Pharmacy & Compounding Center is recalling all unexpired lots of Dexamethosone/Tobramycin pf 0.1%/0.3% ophthalmic drops. The recall was initiated due to concerns regarding quality control procedures that present a potential risk to sterility assurance.
These quality control issues were observed during a recent FDA inspection. The recall covers all lots of sterile products compounded by the pharmacy that have not expired.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- Dexamethosone/Tobramycin pf 0.1%/0.3% ophthalmic
- 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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