Well Care Compounding Pharmacy Recalls QUAD-MIX #4 Due to Sterility Concerns
Well Care Compounding Pharmacy is recalling QUAD-MIX #4 (MOD) vials because FDA inspections found violations that may affect product 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 failure) where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
Well Care Compounding Pharmacy in Las Vegas, Nevada, is recalling QUAD-MIX #4 (MOD), a prescription-only medication packaged in 5mL vials. The recall involves 869 units 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 specific illnesses or injuries associated with these units.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- QUAD-MIX #4 (MOD), packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Manufacturer
- Well Care Compounding Pharmacy
- Category
- Drug — Compounded Prescription
- 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 (6)
- Lot #: 02052016:96@38
- Exp.05/09/2016
- Lot #: 04052016: 39@6
- Exp. 07/04/2016
- Lot #: 04132016:79@19
- Lot #: 07/13/2016.
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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