D-1442-2015 Class II Terminated
FDA drug recall D-1442-2015 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: 2923 mL total volume.
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
- 2923 mL total volume
Product Description
Ascorbic Acid 500 mg/ml Injectable Vial, Sterile Multi-Dose Vial, 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; 05052015@1, 8/3/2015; 03112015@4, 6/9/2015; 03122015@32, 6/10/2015; 03122015@90, 6/10/2015; 03232015@6, 6/21/2015; 03272015@38, 6/25/2015; 04072015@21, 7/6/2015; 05112015@75, 8/9/2015; 04222015@9, 7/21/2015