10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium Services, LLC.
FDA recall notice · announced August 15, 2018 · Pharmedium Services
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium Services, LLC.
Reason for recall
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Notes
Distribution: Product was distributed throughout the United States
Lot/code information: Lot 181780003D
Quantity: 575 Syringes
Status: Terminated
Products in this recall event:
- 5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in 5 mL BD Syringe Kit Check Tagged, PharMEDium Services, LLC. (D-1044-2018)
- 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag and 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravi (D-1043-2018)
- 10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium Services, LLC. (D-1045-2018)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.