Missouriwatcher
Editor, Senior Moderator
Recall #1: American Regent Initiates Voluntary Nationwide Recall of
Bacteriostatic Sodium Chloride Injection, USP, 0.9%
30 mL Multiple Dose Vials
This recall, initiated on March 15, 2011 to the User Level, is for
the following lots of Bacteriostatic Sodium Chloride Injection, USP, 0.9%
30 mL Multiple Dose Vials: NDC # 0517-0648-25
Lot # /Expiration Date / First Distribution Date
9330 ... 05/2011 ... 06/18/2009
9599 ... 08/2011 ... 10/12/2009
9828 ... 12/2011 ... 03/16/2010
This voluntary recall was initiated because some of the vials of these lots may contain visible particulates. Potential adverse events after intravenous administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness due to accumulation of inflammatory cells), and granuloma formation. American Regent is undertaking this voluntary recall in consideration of the potential for safety issues if these lots of product are administered to patients.
The product was distributed to wholesalers and distributors nationwide.
Bacteriostatic Sodium Chloride Injection, USP, 0.9% is used for preparing and diluting sterile solutions.
Hospitals, infusion centers, clinics and other healthcare facilities should not use American Regent Inc., Bacteriostatic Sodium Chloride Injection, USP, 30 mL Multiple Dose Vials with the lot #s listed above for patient care and should immediately quarantine any product for return...
http://www.fda.gov/Safety/Recalls/ucm247402.htm
Recall #2: American Regent Initiates Voluntary Nationwide Recall of Concentrated Sodium Chloride Injection, USP, 23.4% 30 mL Single Dose Vials and 100 mL Pharmacy Bulk Packs
Concentrated Sodium Chloride Injection, USP, 23.4%, 30 mL Single Dose Vial NDC # 0517-2930-25 and
Concentrated Sodium Chloride Injection, USP, 23.4%, 100 mL Pharmacy Bulk Package NDC # 0517-2900-25
PLEASE NOTE: This voluntary nationwide recall, initiated on March 15, 2011 to the User Level, is for Concentrated Sodium Chloride Injection, USP 23.4%, 30 mL Single Dose Vials and 100mL Pharmacy Bulk Packages. See attached APPENDIX for ALL the lots subject to this recall. GO TO WEBSITE
This voluntary recall was initiated because some of the vials of these lots may contain visible particulates. Potential adverse events after intravenous administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness due to accumulation of inflammatory cells), and granuloma formation. American Regent is undertaking this voluntary recall in consideration of the potential for safety issues if these lots of product are administered to patients.
Concentrated Sodium Chloride Injection, USP, 23.4% is indicated as an additive in parenteral fluid therapy for use in patients who have special problems of sodium electrolyte intake or excretion. It is intended to meet the specific requirement of the patient with unusual fluid and electrolyte needs.
The product was distributed to wholesalers and distributors nationwide.
http://www.fda.gov/Safety/Recalls/ucm247398.htm
Recall #3 March 16, 2011 - American Regent is conducting a nationwide voluntary recall of the following:
Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 1 mL Single Dose Vials
NDC # 0517-4901-25;
and
Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 5 mL Multiple Dose Vials
NDC # 0517-4905-25;
and
Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 30 mL Multiple Dose Vials
NDC # 0517-4930-25
PLEASE NOTE: This voluntary recall, initiated on March 16, 2011 to the User Level, is for ALL unexpired lots of all 3 sizes of Dexamethasone Sodium Phosphate Injection, USP. See attached Appendix for Lot #s, Expiration Dates and Dates of First Distribution. GO TO WEBSITE
http://www.fda.gov/Safety/Recalls/ucm247526.htm
Bacteriostatic Sodium Chloride Injection, USP, 0.9%
30 mL Multiple Dose Vials
This recall, initiated on March 15, 2011 to the User Level, is for
the following lots of Bacteriostatic Sodium Chloride Injection, USP, 0.9%
30 mL Multiple Dose Vials: NDC # 0517-0648-25
Lot # /Expiration Date / First Distribution Date
9330 ... 05/2011 ... 06/18/2009
9599 ... 08/2011 ... 10/12/2009
9828 ... 12/2011 ... 03/16/2010
This voluntary recall was initiated because some of the vials of these lots may contain visible particulates. Potential adverse events after intravenous administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness due to accumulation of inflammatory cells), and granuloma formation. American Regent is undertaking this voluntary recall in consideration of the potential for safety issues if these lots of product are administered to patients.
The product was distributed to wholesalers and distributors nationwide.
Bacteriostatic Sodium Chloride Injection, USP, 0.9% is used for preparing and diluting sterile solutions.
Hospitals, infusion centers, clinics and other healthcare facilities should not use American Regent Inc., Bacteriostatic Sodium Chloride Injection, USP, 30 mL Multiple Dose Vials with the lot #s listed above for patient care and should immediately quarantine any product for return...
http://www.fda.gov/Safety/Recalls/ucm247402.htm
Recall #2: American Regent Initiates Voluntary Nationwide Recall of Concentrated Sodium Chloride Injection, USP, 23.4% 30 mL Single Dose Vials and 100 mL Pharmacy Bulk Packs
Concentrated Sodium Chloride Injection, USP, 23.4%, 30 mL Single Dose Vial NDC # 0517-2930-25 and
Concentrated Sodium Chloride Injection, USP, 23.4%, 100 mL Pharmacy Bulk Package NDC # 0517-2900-25
PLEASE NOTE: This voluntary nationwide recall, initiated on March 15, 2011 to the User Level, is for Concentrated Sodium Chloride Injection, USP 23.4%, 30 mL Single Dose Vials and 100mL Pharmacy Bulk Packages. See attached APPENDIX for ALL the lots subject to this recall. GO TO WEBSITE
This voluntary recall was initiated because some of the vials of these lots may contain visible particulates. Potential adverse events after intravenous administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness due to accumulation of inflammatory cells), and granuloma formation. American Regent is undertaking this voluntary recall in consideration of the potential for safety issues if these lots of product are administered to patients.
Concentrated Sodium Chloride Injection, USP, 23.4% is indicated as an additive in parenteral fluid therapy for use in patients who have special problems of sodium electrolyte intake or excretion. It is intended to meet the specific requirement of the patient with unusual fluid and electrolyte needs.
The product was distributed to wholesalers and distributors nationwide.
http://www.fda.gov/Safety/Recalls/ucm247398.htm
Recall #3 March 16, 2011 - American Regent is conducting a nationwide voluntary recall of the following:
Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 1 mL Single Dose Vials
NDC # 0517-4901-25;
and
Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 5 mL Multiple Dose Vials
NDC # 0517-4905-25;
and
Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 30 mL Multiple Dose Vials
NDC # 0517-4930-25
PLEASE NOTE: This voluntary recall, initiated on March 16, 2011 to the User Level, is for ALL unexpired lots of all 3 sizes of Dexamethasone Sodium Phosphate Injection, USP. See attached Appendix for Lot #s, Expiration Dates and Dates of First Distribution. GO TO WEBSITE
http://www.fda.gov/Safety/Recalls/ucm247526.htm