Home / Recalls / SCA Pharmaceuticals / D-0830-2022

D-0830-2022 Class II Terminated

Recalled by SCA Pharmaceuticals — Windsor, CT

Recall Details

Product Type
Drugs
Report Date
May 11, 2022
Initiation Date
April 25, 2022
Termination Date
September 9, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
424 bags

Product Description

Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0231-32

Reason for Recall

CGMP Deviations

Distribution Pattern

Product was distributed nationwide within the United States

Code Information

Lot #: 1222035837, Exp. Date 22-Jul-22 Lot #: 1222035804, Exp. Date 25-Jul-22

Other recalls by SCA Pharmaceuticals

  • D-0417-2024 Class II — PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentrati (November 9, 2023)
  • D-0410-2024 Class II — HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration (November 9, 2023)
  • D-0400-2024 Class II — fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL In (November 9, 2023)
  • D-0396-2024 Class II — fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE (November 9, 2023)
  • D-0405-2024 Class II — HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = (November 9, 2023)
  • D-0414-2024 Class II — PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentrati (November 9, 2023)
  • D-0424-2024 Class II — SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fi (November 9, 2023)
  • D-0416-2024 Class II — PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration (November 9, 2023)
  • D-0401-2024 Class II — fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL I (November 9, 2023)
  • D-0395-2024 Class II — fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 (November 9, 2023)