Well Care Compounding Pharmacy Recalls Methylcobalamin Due to Sterility Concerns
Well Care Compounding Pharmacy is recalling Methylcobalamin 5mg/mL vials because FDA inspections found GMP 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 involves a risk-of-harm product (sterility issues) 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 Methylcobalamin 5mg/mL, packaged in 1mL and 5mL vials. The recall involves 869 units of the prescription-only medication.
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 01262016:77@53, with an expiration date of 04/25/2016. The product was distributed in Nevada.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for instructions on disposal or replacement.
The recalled product
- Product
- METHYLCOBALAMIN 5MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Manufacturer
- Well Care Compounding Pharmacy
- Category
- Drug — Injectable Medication
- 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 #: 01262016:77@53
- Exp. 04/25/2016
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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