Wells Pharmacy Recalls MIC/B12 Injectable Vials Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 633 vials of MIC/B12 Injectable due to a lack of assurance of sterility. The affected products were distributed nationwide.
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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall must be scored as 4 (Severe) regardless of whether specific injuries are reported in the text.
Plain-English summary
Wells Pharmacy Network LLC is voluntarily recalling 633 vials of MIC/B12(M) 15 mg/50 mg/100 mg/1 mg/mL Injectable. The recall is being conducted because of a lack of assurance of sterility in the compounded product. The affected vials are 30 mL units prepared by Wells Pharmacy in Ocala, Florida.
The recall covers 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 04222016@4, 05112016@24, 05162016@14, 06082016@8, 06222016@42, and 07272016@8. The products were distributed nationwide.
Consumers and healthcare providers should stop using the affected vials and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- MIC/B12(M) 15 mg/50 mg/100 mg/1 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Compounded Injectable
- Affected units
- 633
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. Known lot code: 04222016@4
- 05112016@24
- 05162016@14
- 06082016@8
- 06222016@42
- 07272016@8
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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