Recalls / Class II
Class IID-0202-2017
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
- Affected lot / code info
- Lot: 8995
Why it was recalled
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Recalling firm
- Firm
- Cantrell Drug Company
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 7321 Cantrell Rd, Little Rock, Arkansas 72207-4144
Distribution
- Quantity
- 5067 syringes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-11-18
- FDA classified
- 2016-12-13
- Posted by FDA
- 2016-12-21
- Terminated
- 2020-04-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0202-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.