Well Care Compounding Pharmacy Recalls M.I.C. Injection Due to Sterility Concerns
Well Care Compounding Pharmacy is recalling M.I.C. /MB12/B6/DEXPLAN/L-CARN injection vials because FDA inspections found GMP violations that may affect 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 3/5 (High).
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 involves a risk-of-harm product (sterility failure in an injectable drug) where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
Well Care Compounding Pharmacy in Las Vegas, Nevada, is recalling 869 units of M.I.C. /MB12/B6/DEXPLAN/L-CARN, 25MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials. The product is prescription-only and was distributed in Nevada.
The recall was initiated because FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product. The source text does not report any illnesses or injuries associated with the use of these vials.
Patients who have received this medication should contact their healthcare provider for guidance. The recall covers specific lots with expiration dates ranging from March 2016 to June 2016.
The recalled product
- Product
- M.I.C. /MB12/B6/DEXPLAN/L-CARN, 25MG/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 — Compounded Injectable
- 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 (14)
- Lot #: 01222016:57@21
- Exp.03/33/2016
- Lot #: 01222016: 78@51
- Exp.04/25/2016
- Lot #: 01272016:51@23
- Exp. 03/27/2016
- Lot #: 02292016:71@13
- Exp. 04/29/2016
- Lot #: 03022016:46@14
- Exp. 06/22/2016
- Lot #:04252016:20@62
- Exp.06/24/2016
- Lot #: 04262016:18@11
- Exp.06/25/2016
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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