PharMEDium Recalls Rocuronium Bromide Syringes Due to Sterility Assurance Issues
PharMEDium Services, LLC is recalling 46 lots of rocuronium bromide syringes because of a lack of sterility assurance. The products were distributed nationwide in the US.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. The hazard involves a lack of sterility assurance in an intravenous drug, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.
Plain-English summary
PharMEDium Services, LLC is recalling 46 lots of rocuronium bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use. The recall is being conducted because of a lack of sterility assurance.
The affected product is identified by NDC 71019-321-05. The recall covers 2,250 units that were distributed nationwide in the US. Specific lot codes and expiration dates are listed in the official recall notice.
Consumers and healthcare providers should stop using the affected product and contact the recalling firm for further instructions.
The recalled product
- Product
- rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use, PharMEDium 13N. Davis Ave. Cleveland MS 36732. NDC 71019-321-05
- Manufacturer
- PharMEDium Services, LLC
- Category
- Drug — Injectable Medication
- Affected units
- 2,250
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)
- 193500019D 3/16/2020 193510014D 3/17/2020 193520009D 3/18/2020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 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.
See all 13 products in this recall →Related recalls
Same manufacturer · PharMEDium Services, LLC
See all →- SeverePharMEDium Recalls Hydromorphone Syringes Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls nICARdipine HCl Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls ePHEDrine Sulfate Syringes Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Rocuronium Bromide Syringes Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Fentanyl Citrate Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-04-15
Same hazard · lack of sterility assurance
See all →- SevereNAD+ Pre-Filled Syringes Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2025-07-02
- ModerateTirzepatide Injections Pre-filled Syringe Recalled for Sterility Assurance
FDA (Drugs) · 2025-07-02
- HighPHENYLephrine HCl Injectable Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2024-04-03
- HighHydromorphone Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2024-04-03
- HighFentanyl Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2023-10-11