Wells Pharmacy Recalls B-Complex Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling B-complex + Vit C injectable vials 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility issue) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Wells Pharmacy Network LLC is recalling 180 vials of B-complex + Vit C 20 mg/mL Injectable, 30 mL vial. The recall is due to a lack of assurance of sterility. The affected product was compounded by Wells Pharmacy Network, LLC, in Ocala, FL.
The recall includes all lot codes of the product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot codes include 03252016@2, 04292016@11, 06122016@9, and 07212016@11. The product was distributed nationwide.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- B-complex + Vit C 20 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy Network, LLC, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 180
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 (5)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. Known lot code: 03252016@2
- 04292016@11
- 06122016@9
- 07212016@11
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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