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U.S. Department of Health and Human Services

Safety

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American Regent Injectable Products: Recall - Visible Particulates in Products

  • Calcium Gluconate Injection, USP, 10%, 100 mL Pharmacy Bulk Package (Lot #1006)
  • Concentrated Sodium Chloride Injection, USP 23.4%, 30 mL Single Dose Vials (Lot #0362)
  • Methyldopate HCL Injection, USP 5ml Single Dose Vial
  • Caffeine & Sodium Benzoate Injection, USP, 250 mg/mL, 2 mL Single Dose Vial
  • Ammonium Molybdate Injection, USP (Molybdenum 250mcg/10 mL) 10 mL Single Dose Vial
  • Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 1 mL Single Dose Vials; 5 mL and 30 mL Multiple Dose Vials
  • Bacteriostatic Sodium Chloride Injection, USP, 0.9%, 30 mL Multiple Dose Vials
  • Concentrated Sodium Chloride Injection, USP 23.4%, 30 mL Single Dose Vials and 100mL Pharmacy Bulk Packages
  • Sodium Thiosulfate Injection USP 10%
  • Potassium Phosphates Injection, USP
  • Phenylephrine HCl Injection USP 1%
  • Cyanocobalamin Injection, USP, (1000 mcg/mL), 1mL Vial  (Lot# 1662,1679 and 1683) 

 

[UPDATED 04/04/2012] Cyanocobalamin Injection, USP, (1000 mcg/mL), 1mL Vial (Lot# 1662,1679 and 1683) recalled - because cracks can form in the heel (bottom) and sides of some vials of these lots. These cracks may lead to a lack of assurance of sterility and the potential for development of glass particulates.
 

[UPDATED 02/23/2012] Phenylephrine HCl Injection, USP, 1% 5 mL Vial, (Lot# 0693) recalled.

[UPDATED 07/20/2011] Calcium Gluconate Injection, USP, 10%, 100 mL Pharmacy Bulk Package (Lot #1006) recalled.

[UPDATED 06/07/2011] Methyldopate HCL Injection, USP 5ml Single Dose Vial recalled. See Press Release for lot information.

[UPDATED 05/06/2011] Caffeine & Sodium Benzoate Injection, USP, 250 mg/mL, 2 mL Single Dose Vial recalled. See Press Release for lot information.

[UPDATED 04/27/2011] Ammonium Molybdate Injection, USP (Molybdenum 250mcg/10 mL) 10 mL Single Dose Vial recalled. See Press Release for lot information.

[UPDATED 03/18/2011]  Dexamethasone Sodium Phosphate Injection products recalled. See Press Release for lot information.

[UPDATED 03/17/2011] Concentrated Sodium Chloride Injection products recalled. See Press Release for lot information.

[Posted 02/05/2011]

 

AUDIENCE: Pharmacy

ISSUE: Recall initiated because some vials exhibit translucent visible particles consistent with glass delamination. Potential adverse events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation.

BACKGROUND: Glass delamination can occur with high pH solutions when the surface glass from the vial separates into thin layers, resulting in glass particles with a flaky appearance.

RECOMMENDATION: Hospitals, Home Health Care Agencies, Emergency Rooms, Infusion Centers, Clinics and other healthcare facilities should not use the recalled American Regent products. Recalled products should be immediately quarantined for return. Refer to Press Releases for specific lot numbers recalled.

 

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

[04/04/2012 - Press Release, Cyanocobalamin Injection, American Regent]
[02/23/2012 - Press Release, Phenylephrine HCl Injection, American Regent]
[07/18/2011 - Press Release, Calcium Gluconate Injection, American Regent]
[06/15/2011 - Press Release, Concentrated Sodium Chloride - American Regent]
[06/06/2011 - Press Release, Methyldopate HCL Injection - American Regent]
[05/05/2011 - Press Release, Caffeine & Sodium Benzoate Injection - American Regent]
[04/26/2011 - Press Release, Ammonium Molybdate Injection - American Regent]
[03/16/2011 - Press Release, Dexamethasone Sodium Phosphate - American Regent]
[03/15/2011 - Press Release, Bacteriostatic Sodium Chloride - American Regent] 
[03/15/2011 - Press Release, Concentrated Sodium Chloride - American Regent] 
[02/04/2011 - Press Release, Sodium Thiosulfate - American Regent]
[02/03/2011 - Press Release, Potassium Phosphates - American Regent]   

Previous, related product alerts:

[12/24/2010 - Dexamethasone Sodium Phosphate Injection]
[12/29/2010 - Sodium Bicarbonate Injection]

 

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