Rocuronium Bromide Injection recall
FDA recall D-0371-2024 · initiated Feb 7, 2024
Mckesson Medical-Surgical Inc. Corporate Office recalled Rocuronium Bromide Injection in Feb 2024 — an FDA Class II recall (D-0371-2024) because cGMP Deviations: Products were stored outside the drug label specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
cGMP Deviations: Products were stored outside the drug label specifications.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 70 vials
Details
- Product
- Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma LLC, NDC 55150-226-10
- Recalling company
- Mckesson Medical-Surgical Inc. Corporate Office
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Product was distributed to three direct accounts in NM, AZ and UT.
- Initiated
- Feb 7, 2024
- FDA report date
- Mar 20, 2024
Frequently asked
- Was Rocuronium Bromide Injection recalled?
- Mckesson Medical-Surgical Inc. Corporate Office recalled Rocuronium Bromide Injection in Feb 2024 — an FDA Class II recall (D-0371-2024) because cGMP Deviations: Products were stored outside the drug label specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Rocuronium Bromide Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0371-2024 was: cGMP Deviations: Products were stored outside the drug label specifications.
- Is a recalled Rocuronium Bromide Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Rocuronium Bromide Injection are affected?
- Distributed: Product was distributed to three direct accounts in NM, AZ and UT.. The recall covers these lots — 1064081. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0371-2024.