Drug product
Rocuronium Bromide 50 mg/5 mL Injection Solution, 5 mL (10 mg/mL) Single-Dose Syringe, Injection Solution For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-064-15
D-0202-2017
Product summary
- Event
- Event 75745
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5067 syringes
- Official record key
drug-enforcement:D-0202-2017
Official wording
Reason: Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Code information: Lot: 8995
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility