D-1005-2016 Class II Terminated
FDA drug recall D-1005-2016 was initiated by Well Care Compounding Pharmacy on May 17, 2016 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. The recall status is terminated (terminated January 13, 2017). Affected quantity: 869 Units (Total All Products).
Recall Details
- Product Type
- Drugs
- Report Date
- June 15, 2016
- Initiation Date
- May 17, 2016
- Termination Date
- January 13, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 869 Units (Total All Products)
Product Description
PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID- 5%/4.75%, packaged in 10mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Reason for Recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Distribution Pattern
NV
Code Information
Lot #: 01252016:44@43, Exp. 07/26/2016.