D-1518-2015 Class II Terminated
FDA drug recall D-1518-2015 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: 695 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
- 695 ml total
Product Description
HCG 1,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate 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; 04092015@6,6/8/2015; 04202015@38, 6/19/2015; 04202015@8, 6/19/2015; 03202015@99, 5/22/2015; 03302015@54, 5/29/2015; 03312015@56, 5/30/2015; 04072015@7, 6/6/2015; 04062015@56, 6/5/2015; 04142015@86, 6/13/2015; 05052015@49, 7/4/2015; 05062015@30, 7/5/2015