Rocuronium Bromide Injection Lacks Paralyzing Agent Warning
Piramal Critical Care is recalling Rocuronium Bromide Injection because the finished product vial lacks the required "WARNING: PARALYZING AGENT" statement on the flip cap. The missing warning could lead to unsafe use of this prescription neuromuscular-blocking drug.
What this means for you
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: This is an FDA Class II recall involving a labeling deficiency—specifically, a missing required warning statement on the product vial. The source text does not report any illnesses or injuries resulting from the missing label, and the hazard is a labeling/documentation issue rather than contamination or structural failure. This matches the Moderate severity criterion for labeling errors and voluntary precautionary recalls.
Plain-English summary
Piramal Critical Care, Inc. is recalling Rocuronium Bromide Injection 50mg/5mL in 5mL multi-dose glass vials because the finished product does not include the statement "WARNING: PARALYZING AGENT" on the flip cap vial label. This is a required warning for this prescription medication.
The recalled product was distributed nationwide within the United States. Affected lots are #20415001 and #20415002, with an expiration date of 05/2022. The product is manufactured by Sanovel Ilac in Istanbul, Turkey, for Piramal Critical Care in Bethlehem, Pennsylvania (NDC 66794-0228-41).
Rocuronium Bromide is a neuromuscular-blocking agent used in clinical settings. The absence of the paralyzing agent warning on the vial label creates a risk that the medication could be used unsafely. Healthcare facilities and providers who have this product should stop using it and contact Piramal Critical Care for replacement stock with proper labeling.
The recalled product
- Product
- Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufactured for: Piramal Critical Care, Bethlehem, PA 18017, USA, Manufactured by: Sanovel Ilac, San. Ve Tic. A.S. Istanbul, Turkey, NDC 66794-0228-41
- Manufacturer
- Piramal Critical Care, Inc.
- Hazard
- missing-warning-label
- labeling-error
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 (3)
- Lot #: 20415001
- 20415002
- Expiration Date 05/2022
Distribution
Distributed nationwide across the United States.
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