Wells Pharmacy Recalls Trimix Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling Trimix Injectable vials because the agency could not ensure the product was sterile.
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 property damage reports or high-risk scenarios.
Plain-English summary
Wells Pharmacy Network LLC is recalling Trimix Injectable 30 mg/3 mg/100 mcg/mL, 5 mL and 10 mL vials, compounded in Ocala, Florida. The recall is due to a lack of assurance of sterility for the product.
The affected products were prepared between February 22, 2016, and September 14, 2016, and are within their expiration dates. Specific known lot codes include 07192016@7 and 04122016@18. The products were distributed nationwide.
Consumers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Trimix Injectable 30 mg/3 mg/100 mcg/mL, a) 5 mL and 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Injectable
- 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 codes of product prepared between 02/22/2016 and 09/14/2016
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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