Wells Pharmacy Recalls Bimix Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling Bimix 30 mg/1 mg/mL Injectable vials 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, which corresponds to a Severe severity score under the rubric for drug recalls involving potential serious health consequences.
Plain-English summary
Wells Pharmacy Network LLC, located in Ocala, Florida, is recalling Bimix 30 mg/1 mg/mL Injectable vials. The recall covers 5 mL and 10 mL vials prepared between February 22, 2016, and September 14, 2016. The total quantity involved is 80 vials of the 5 mL size and 23 vials of the 10 mL size.
The reason for the recall is a lack of assurance of sterility. The product was distributed nationwide. Specific lot codes affected include 04012016@7, 04252016@17, 05262016@13, 06142016@39, and 08052016@13 for the 5 mL vials, and 05242016@11 and 09072016@18 for the 10 mL vials.
Consumers and healthcare providers should check their inventory for these specific lot codes and dates. If the product is found, it should be stopped from use and returned to the pharmacy or contact the recalling firm for instructions.
The recalled product
- Product
- Bimix 30 mg/1 mg/mL Injectable, a) 5 mL and b) 10 mL vial, Compounded by Wells Pharmacy Network, LLC, 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 (7)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. a) Known lot code: 04012016@7
- 04252016@17
- 05262016@13
- 06142016@39
- 08052016@13 b) Known lot code: 05242016@11
- 09072016@18
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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