Well Care Compounding Pharmacy Recalls QUAD-MIX #3 Due to Sterility Concerns
Well Care Compounding Pharmacy is recalling QUAD-MIX #3 vials because FDA inspections found violations that may affect product 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of sterility failure in a compounded injectable medication.
Plain-English summary
Well Care Compounding Pharmacy in Las Vegas, Nevada, is recalling QUAD-MIX #3, a prescription-only medication packaged in 5mL vials. The recall involves 869 units distributed in Nevada.
The recall was initiated after an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility. The specific lots affected are 011520J6:90@35 (expiring 04/17/2016) and 04282016:23@31 (expiring 08/01/2016).
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.
The recalled product
- Product
- QUAD-MIX #3, 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 (4)
- Lot #: 011520J6:90@35
- Exp.04/17/2016
- Lot #: 04282016:23@31
- Exp.08/01/2016.
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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