Well Care Compounding Pharmacy Recalls QUAD-MIX #1 Due to Sterility Concerns
Well Care Compounding Pharmacy is recalling QUAD-MIX #1 vials because FDA inspections found violations that may affect sterility.
What this means for you
Illness, injury, or structural failure has been reported. 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, and the hazard involves a lack of assurance of sterility in a parenteral product, which carries a risk of serious injury.
Plain-English summary
Well Care Compounding Pharmacy in Las Vegas, Nevada, is recalling QUAD-MIX #1, 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 product's quality and sterility. The affected lots are 01292016:04@9 (expiring 07/27/2016) and 04082016: 84@17 (expiring 10/09/2016).
Patients who have received this medication should contact their healthcare provider for guidance on whether to discontinue use or obtain a replacement.
The recalled product
- Product
- QUAD-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Manufacturer
- Well Care Compounding Pharmacy
- Category
- Drug — Compounded Prescription
- 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 (4)
- Lot #: 01292016:04@9
- Exp.07/27/2016
- Lot #: 04082016: 84@17
- Exp. 10/09/2016.
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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