Wells Pharmacy Recalls Sodium Bicarbonate Injectable Vials Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 67 vials of Sodium Bicarbonate, 8.4% Injectable, 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable product, which poses a significant risk of infection or serious injury, aligning with the 'Severe' criteria for significant injury reports or high-risk defects.
Plain-English summary
Wells Pharmacy Network LLC is recalling 67 vials of Sodium Bicarbonate, 8.4% Injectable, 30 mL MultiDose vials. The product was compounded by Wells Pharmacy in Ocala, Florida, 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 February 22, 2016, and September 14, 2016, that are within their expiration dates. Specific known lot codes include 04062016@4, 05232016@120, 06142016@9, and 09122016@9.
Consumers and healthcare providers should check their inventory for these specific lot codes and dates. If the product is found, it should be removed from use and returned to the pharmacy or disposed of according to local regulations. No specific instructions for disposal are provided in the source text.
The recalled product
- Product
- Sodium Bicarbonate, 8.4% Injectable, 30 mL MultiDose vial, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Injectable
- Affected units
- 67
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: 04062016@4
- 05232016@120
- 06142016@9
- 09122016@9.
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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