Wells Pharmacy Recalls Ceftazidime Ophthalmic Kits Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 46 kits of compounded Ceftazidime Ophthalmic 2.25% due to a lack of assurance of sterility.
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, and the rubric specifies that FDA Class II recalls with potential for serious injury or hospitalization (implied by sterility failure in an ophthalmic product) fall under the Severe category.
Plain-English summary
Wells Pharmacy Network LLC is recalling 46 kits of Ceftazidime, Lyophilized, Ophthalmic 2.25% Kit, Rx only. The product was compounded by Wells Pharmacy in Ocala, FL, and distributed nationwide. The recall is being conducted because of a lack of assurance of sterility.
The recall includes all lot codes of the product prepared between 02/22/2016 and 09/14/2016, within expiry. A known kit lot code is 06062016@118, and a vial lot code is 05272016@47. The number of vials per kit varies by prescription.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions.
The recalled product
- Product
- Ceftazidime, Lyophilized, Ophthalmic 2.25% Kit, Rx only, Compounded by Wells Pharmacy, Ocala , FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 46
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 (2)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. Known kit lot code: 06062016@118. Vial lot code 05272016@47
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 97 recalled by Wells Pharmacy Network LLC 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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