Recalls / Class II
Class IID-1079-2017
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
- Affected lot / code info
- 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
Why it was recalled
Lack of Sterility Assurance.
Recalling firm
- Firm
- Cantrell Drug Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7321 Cantrell Rd, N/A, Little Rock, Arkansas 72207-4144
Distribution
- Quantity
- 28779 syringes
- Distribution pattern
- Nationwide within the US
Timeline
- Recall initiated
- 2017-07-14
- FDA classified
- 2017-08-09
- Posted by FDA
- 2017-08-16
- Terminated
- 2020-09-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1079-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.