PharMEDium Recalls Rocuronium Bromide Syringes Due to CGMP Deviations
PharMEDium Services, LLC is recalling 575 syringes of 10 mg/mL Rocuronium Bromide because the product was released while a hood certification discrepancy was under investigation.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a CGMP deviation (hood certification discrepancy) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
PharMEDium Services, LLC is recalling 575 syringes of 10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe. The product is identified by Lot 181780003D and was distributed throughout the United States.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the product was released while a hood certification discrepancy was being investigated. This procedural issue raises concerns about the sterility and quality control of the medication during the manufacturing process.
Healthcare providers and patients who have this specific lot of Rocuronium Bromide should stop using it and contact their pharmacist or the recalling firm for instructions on return or disposal. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium Services, LLC.
- Manufacturer
- PharMEDium Services, LLC
- Category
- Drug — Injectable Medication
- Affected units
- 575
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 181780003D
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by PharMEDium Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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