D-1690-2015 Class II Terminated
FDA drug recall D-1690-2015 was initiated by The Compounding Pharmacy of America on June 2, 2015 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 February 10, 2016). Affected quantity: 775 ml.
Recall Details
- Product Type
- Drugs
- Report Date
- September 23, 2015
- Initiation Date
- June 2, 2015
- Termination Date
- February 10, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 775 ml
Product Description
Lipotropic (w/Cyanocobalamin 4000 mcg/ml) Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Distribution Pattern
Nationwide
Code Information
All lots distributed between November 2014 and May 2015; 05062015@1, 7/31/2015; 04152015@62, 7/14/2015; 03232015@53, 6/21/2015; 03232015@75, 6/21/2015; 04152015@11, 7/14/2015