FDAFDA · Food and drugs·Recall number D-1005-2016
PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID- 5%/4.75%, packaged in 10mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Published June 15, 2016 · Recall initiated: May 17, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Well Care Compounding Pharmacy
- Distributor
- NV
- Lot
- Lot #: 01252016:44@43, Exp. 07/26/2016.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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