Home / Recalls / SCA Pharmaceuticals, LLC / D-0062-2018

D-0062-2018 Class II Terminated

Recalled by SCA Pharmaceuticals, LLC — Little Rock, AR

Recall Details

Product Type
Drugs
Report Date
November 8, 2017
Initiation Date
October 19, 2017
Termination Date
May 1, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
116 bags

Product Description

fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250 mL) in 0.9% Sodium Chloride 250 mL Bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205. NDC 70004-0231-40

Reason for Recall

Lack Of Assurance Of Sterility.

Distribution Pattern

Nationwide in the United States

Code Information

Lot: 20170814@20 BUD: 11/12/2017

Other recalls by SCA Pharmaceuticals, LLC

  • D-0405-2024 Class II — HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = (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)
  • 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-0416-2024 Class II — PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration (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-0410-2024 Class II — HYDROmorphone HCl 30 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-0417-2024 Class II — PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentrati (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-0423-2024 Class II — SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 mL (November 9, 2023)