CLASS II Drug recall · Reported 20 Mar 2024 · FDA Enforcement Report
Rocuronium Bromide Injection, Preservative Free, 10 mg / mL recalled
Mckesson Medical-Surgical Inc. Corporate Office is recalling Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial, distributed in Arizona, New Mexico, Utah. The recall was initiated on 7 Feb 2024 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-0371-2024
- FDA event ID
- 93935
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA
- Brand
- Rocuronium Bromide
- Manufacturer
- Eugia US LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Feb 2024
- FDA classified
- 8 Mar 2024
- Reported
- 20 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 7 Feb 2024 | Recall initiated by company | |
| 8 Mar 2024 | Classified by FDA | +30 days |
| 20 Mar 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP Deviations: Products were stored outside the drug label specifications.
Product as listed by the FDA
Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma LLC, NDC 55150-226-10
Where it was distributed
Product was distributed to three direct accounts in NM, AZ and UT.
Questions about this recall
Why was it recalled?
cGMP Deviations: Products were stored outside the drug label specifications.
Which lots are affected?
1064081
Where was it sold?
Product was distributed to three direct accounts in NM, AZ and UT.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 93935This product is part of a recall event; the main page for the event is Bicillin L-A (Penicillin G Benzathine) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Bicillin L-A (Penicillin G Benzathine) recalled | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | AZ, NM, UT | |
| CLASS II | Infuvite Adult Multiple vitamins injection, single-dose vial recalled | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | AZ, NM, UT |
More recalls from Mckesson Medical-Surgical Inc. Corporate Office
All 276| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived recalled | Mckesson Medical-Surgical Inc. Corporate Office | Other | Nationwide |
| Drug | CLASS II | Prolia (denosumab), injection, 60mg/mL, For Subcutaneous Use Only recalledProlia | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | FL, VA |
| Drug | CLASS II | Benlysta (belimumab) for injection, 400 mg/ vial recalledBenlysta | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | FL, VA |
| Drug | CLASS II | Evenity, (romosozumab -aqqg) injection, 105mg recalledEvenity | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | FL, VA |
| Device | CLASS II | Abbott Diagnostics Alinity I Anti-ccps Reagent recalled | Mckesson Medical-Surgical Inc. Corporate Office | Device Malfunction | Nationwide |
Other Rocuronium recalls
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | rocuronium, 50 mg/, (10 mg/mL) Syringe recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | rocuronium 50 mg/ (10 mg/mL) Syringes recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | rocuronium, 50 mg /, (10 mg/mL) Syringe recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | ROcuronium Bromide 50 mg/ ( 10 mg/mL) Syringe recalled | New England Life Care | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Rocuronium Bromide Injection, 50 mg/ (10 mg/mL) recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |