Home / Recalls / SCA Pharmaceuticals / D-1010-2017

D-1010-2017 Class II Terminated

Recalled by SCA Pharmaceuticals — Little Rock, AR

Recall Details

Product Type
Drugs
Report Date
August 2, 2017
Initiation Date
July 14, 2017
Termination Date
May 1, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

fentaNYL as citrate 5 mcg/mL in 0.9% Sodium Chloride 1 mL in Single Dose syringe, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0225-24

Reason for Recall

Lack of Assurance of Sterility; product has the potential to leak.

Distribution Pattern

Nationwide

Code Information

Lot: 20170510@40 BUD: 8/8/2017

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)