Well Care Compounding Pharmacy recalls PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID- 5%/4.75%, packaged in 10mL vials, Rx only, Well Care Compounding Pharmacy Las Veg
Recalled June 15, 2016 · FDA recall D-1005-2016 · Well Care Compounding Pharmacy
Hazard
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. · FDA Class II
Units
869 Units (Total All Products)
Sold at
NV
Description
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Product
PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID- 5%/4.75%, packaged in 10mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Manufacturer(s)
Well Care Compounding Pharmacy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →