CLASS II Drug recall · Reported 16 Aug 2017 · FDA Enforcement Report
Rocuronium Bromide Injection Solution, 50 mg recalled by Cantrell Drug
Cantrell Drug is recalling Rocuronium Bromide Injection Solution, 50 mg/ (10 mg/mL) Single-Dose Syringe, distributed nationwide in the US. The recall was initiated on 14 Jul 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1079-2017
- FDA event ID
- 77780
- Recalling firm
- Cantrell Drug, Little Rock, AR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Jul 2017
- FDA classified
- 9 Aug 2017
- Reported
- 16 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 14 Jul 2017 | Recall initiated by company | |
| 9 Aug 2017 | Classified by FDA | +26 days |
| 16 Aug 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Sterility Assurance.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Nationwide within the US
Questions about this recall
Is Rocuronium Bromide Injection Solution, 50 mg/ (10 mg/mL) Single-Dose Syringe recalled?
Yes. Cantrell Drug recalled Rocuronium Bromide Injection Solution, 50 mg/ (10 mg/mL) Single-Dose Syringe on 14 Jul 2017. The recall is Class II and its status is Terminated. Recall number D-1079-2017.
Why was it recalled?
Lack of Sterility Assurance.
Which lots are affected?
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
Where was it sold?
Nationwide within the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Cantrell Drug
All 52| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ephedrine Sulfate in 9% Sodium Chloride, 50 mg recalled by Cantrell Drug | Cantrell Drug | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine Bitartrate 4 mg Added to 9% Sodium Chloride recalled | Cantrell Drug | Sterility | Nationwide |
| Drug | CLASS II | Diltiazem HCl 125 mg in 5% Dextrose Single-Dose recalled | Cantrell Drug | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine Bitartrate 8 mg Added to 9% Sodium Chloride recalled | Cantrell Drug | Sterility | Nationwide |
| Drug | CLASS II | Adenosine in 9% Sodium Chloride, 90 mg recalled by Cantrell Drug | Cantrell Drug | Sterility | Nationwide |
Other Rocuronium bromide recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rocuronium Bromide Injection, Preservative Free, 10 mg / mL recalledRocuronium Bromide | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | AZ, NM, UT |
| Drug | CLASS II | Rocuronium Bromide Injection, 50 mg/ (10 mg/mL) recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Rocuronium Bromide Injection, 50 mg/ (10 mg/mL) syringe recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Rocuronium Bromide Injection, 50 mg/ (10 mg/mL) recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Rocuronium Bromide Injection 50mg/ Multi-Dose Vial recalled | Piramal Critical Care | Other | Nationwide |