D-1763-2015 Class II Terminated
FDA drug recall D-1763-2015 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: 25 ml total.
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
- 25 ml total
Product Description
Tri-Mix (17 mg/0.5 mg/6 mcg) Injectable, Sterile, Keep Frozen, 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; 05072015@6, 11/3/2015, 05052015@77, 11/1/2015