FDA Recalls Well Care Compounding Pharmacy M.l.C./B5/B6 Injection for Sterility Concerns
Well Care Compounding Pharmacy is recalling M.l.C./B5/B6 injection vials due to FDA inspection findings of GMP violations that may impact 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 in an injectable) 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./B5/B6 25 MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials. The product is prescription-only and was distributed in Nevada. The recall involves specific lots with expiration dates in March and May 2016.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the quality and sterility of the product, creating a lack of assurance of sterility.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- M.l.C./B5/B6 25 MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Manufacturer
- Well Care Compounding Pharmacy
- Category
- Drug — Injectable
- Hazard
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 (4)
- Lot #: 01272016:00@24
- Exp.03/28/2016
- Lot #: 03292016: 96@35
- Exp. 05/24/2016
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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