Drug product
Rocuronium Bromide Injection Solution 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-064-15
D-1079-2017
Product summary
- Event
- Event 77780
- Status
- Terminated
- Classification
- Class II
- Quantity
- 28779 syringes
- Official record key
drug-enforcement:D-1079-2017
Official wording
Reason: Lack of Sterility Assurance.
Code information: Lot #: 9598, BUD: 8/2/2017; 9609, BUD: 8/5/2017; 9621, BUD: 8/7/2017; 9681, BUD: 8/19/2017; 9765, BUD: 9/5/2017; 10102, BUD: 10/24/2017; 10347, BUD: 11/26/2017; 10357, BUD: 11/26/2017; 10387, BUD: 12/3/2017; 10478, 10505, 10585, BUD: 12/16/2017
Distribution pattern: Nationwide within the US
Derived failure modes
-
Sterility assurance
Lack of Sterility