Well Care Compounding Pharmacy Recalls Methyl B12 Due to Sterility Concerns
Well Care Compounding Pharmacy is recalling Methyl B12 vials because FDA inspections found violations that may affect sterility.
What this means for you
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 the hazard involves a risk of harm (lack of sterility) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Well Care Compounding Pharmacy in Las Vegas, Nevada, is recalling M.l.C. Methyl B12, 25 MG/50MG/25MG/1 MG/ML, packaged in 5mL vials. The product is prescription-only and was distributed in Nevada. A total of 869 units are affected by this recall.
The recall was initiated because FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility. The specific lot number is 03222016:11@22, with an expiration date of 09/20/2016.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider for further instructions or a replacement.
The recalled product
- Product
- M.l.C. Methyl B12, 25 MG/50MG/25MG/1 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Manufacturer
- Well Care Compounding Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 869
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 (2)
- Lot #: 03222016:11@22
- Exp. 09/20/2016
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 51 recalled by Well Care Compounding Pharmacy 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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