Drug product
Autologous Serum Tears, 2 vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402
D-1541-2016
Product summary
- Event
- Event 75164
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 bottles
- Official record key
drug-enforcement:D-1541-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot#: 390325, Use by 08/01/16; 382789, Use by 08/07/16; 396766, Use by 08/11/16; 393470, Use by 08/14/16; 393036, Use by 08/14/16; 398131, Use by 08/15/16; 389288, Use by 08/20/16; 392969, Use by 08/21/16
Distribution pattern: MS
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility