Wells Pharmacy Recalls Methylcobalamin Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling Methylcobalamin 1,000 mcg/mL Injectable vials because the agency could not ensure the product was sterile.
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 recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious health consequences such as infection.
Plain-English summary
Wells Pharmacy Network LLC is voluntarily recalling Methylcobalamin 1,000 mcg/mL Injectable, available in 10 mL and 30 mL vials. The recall was initiated due to a lack of assurance of sterility for the compounded product.
The affected units were prepared between February 22, 2016, and September 14, 2016, and are within their expiration dates. The recall covers 499 ten-milliliter vials and 1,214 thirty-milliliter vials. Specific lot codes for both vial sizes are listed in the official recall documentation.
The product was distributed nationwide. Consumers and healthcare providers should stop using the recalled vials and contact their pharmacist or the recalling firm for instructions on disposal or replacement.
The recalled product
- Product
- Methylcobalamin 1,000 mcg/mL Injectable, a) 10 mL vial and b) 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Injectable
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 (14)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. a) Known lot code: 04062016@5
- 05172016@1
- 06162016@2
- 07202016@47
- 08222016@6 b) Known lot code: 04052016@1
- 05032016@1
- 05182016@1
- 05262016@32
- 06162016@13
- 06232016@74
- 07012016@18
- 08092016@6
- 09062016@33
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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