Western Drug Recalls Tacrolimus Ointment Due to Sterility Concerns
Western Drug is recalling three containers of Tacrolimus 0.03% Ophthalmic Ointment because the product lacks assurance of sterility.
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 recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a risk of serious injury (lack of sterility in an ophthalmic product) corresponds to a severity score of 4 (Severe), as it does not meet the criteria for Class I (Critical) but exceeds the threshold for High due to the potential for significant injury from non-sterile ophthalmic products.
Plain-English summary
Western Drug Inc. is recalling three containers of Tacrolimus 0.03% Ophthalmic Ointment. The recall was initiated because the product lacks assurance of sterility.
The affected product is a prescription ophthalmic ointment manufactured by Western Drug Inc. in Springerville, Arizona. The recall covers all lots of the product.
The product was distributed nationwide in the United States, specifically in Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah. Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- Tacrolimus 0.03% Opth Oint, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
- Manufacturer
- Western Drug
- Category
- Drug — Ophthalmic Ointment
- Hazard
- Affected units
- 3
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 lots
Distribution
Part of a larger recall action
This product is one of 91 recalled by Western Drug 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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