Wells Pharmacy Recalls Methylcobalamin Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 265 vials of compounded Methylcobalamin 5,000 mcg/mL Injectable 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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as lack of sterility in injectables) are categorized as Severe (Score 4), particularly when structural or significant injury risks are implied by the nature of the defect, though no specific hospitalizations are reported in the text, the 'Lack of Assurance of Sterility' for an injectable drug represents a significant risk profile fitting the Severe criteria for non-Class I drug recalls with potential for serious harm.
Plain-English summary
Wells Pharmacy Network LLC is recalling 265 vials of Methylcobalamin 5,000 mcg/mL Injectable, 10 mL vial, compounded by Wells Pharmacy in Ocala, Florida. The recall was initiated because the product lacks assurance of sterility.
The affected product includes all lot codes prepared between February 22, 2016, and September 14, 2016, that are within their expiration date. Specific known lot codes include 04152016@3, 05192016@1, 06132016@23, 07132016@10, 08112016@22, and 09062016@32. The product was distributed nationwide.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist 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
- Methylcobalamin 5,000 mcg/mL Injectable, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Compounded Injectable
- Affected units
- 265
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: 04152016@3
- 05192016@1
- 06132016@23
- 07132016@10
- 08112016@22
- 09062016@32.
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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