Well Care Compounding Pharmacy Recalls Methylcobalamin Vials for Sterility Concerns
Well Care Compounding Pharmacy is recalling 869 vials of Methylcobalamin 12.5mg/mL due to FDA inspection findings of GMP violations that may impact 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text explicitly states no illnesses or injuries have been reported, fitting the criteria for a voluntary precautionary recall or low-risk contamination where the hazard is theoretical.
Plain-English summary
Well Care Compounding Pharmacy in Las Vegas, Nevada, is recalling 869 units of Methylcobalamin 12.5mg/mL, packaged in 5mL vials. The product is prescription-only and was distributed in Nevada. The recall is associated with FDA recall number D-0999-2016.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility. The source text does not report any specific illnesses, injuries, or deaths associated with the use of these products.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for instructions on how to return or dispose of the medication. Specific lot numbers and expiration dates are listed in the official recall documentation.
The recalled product
- Product
- METHYLCOBALAMIN 12.5MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Manufacturer
- Well Care Compounding Pharmacy
- Category
- Drug — 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 (16)
- Lot #: 02022016 : 72@19
- Exp. 07/13/2016
- Lot #: 02092016: 09@23
- Exp. 08/08/2016
- Lot #: 02262016:14@7
- Exp. 08/27/2016
- Lot #:03022016: 60@23
- Exp. 08/21/2016
- Lot #: 03012016:54@20
- Exp.08/24/2016
- Lot #: 03212016: 35@49
- Exp. 09/17/2016
- Lot #: 04142016: 15@2
- Exp. 10/11/2016
- Lot #: 04212016: 69@19
- Exp.10/19/2016.
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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