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Author Topic: American Regent Recalls Bacteriostatic Sodium Chloride Injection, USP, 0.9%  (Read 2565 times)
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JustMe
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My RB Angels Elvis, 1991-2010, and Twit, 2001-2010


« on: March 17, 2011, 10:26:56 AM »

I'm not sure if this would pertain to anyone giving subcutaneous fluids to their cats or dogs, but I was using a 0.9% sodium chloride for Elvis' subcutaneous injections.  This is a different brand than I used and this sounds like it might be used in hospitals only.  Maybe MandyCat would know?  In any event, it is more particulate matter in the fluids, this time it is visible particulate matter.   Angry

http://www.fda.gov/Safety/Recalls/ucm247402.htm

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

American Regent Initiates Voluntary Nationwide Recall of
Bacteriostatic Sodium Chloride Injection, USP, 0.9%
30 mL Multiple Dose Vials
 

Contact:
Walter Tozzi, R.Ph., M.S., M.B.A.
Sr. Director of Professional Services
631-924-4000

FOR IMMEDIATE RELEASE - Shirley, NY March 15, 2011 - American Regent is conducting a nationwide voluntary recall of the three lots listed below of the following product:

Bacteriostatic Sodium Chloride Injection, USP, 0.9%, 30 mL, Multiple Dose Vials

NDC # 0517-0648-25

PLEASE NOTE:  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.

American Regent has identified the source of the particulates and has taken the necessary steps to correct this issue. The company is initiating this voluntary recall for these lots manufactured prior to the implementation of this corrective action. American Regent has informed the FDA of its actions and is maintaining ongoing discussions with the agency.


As is standard practice, and as stated in the Bacteriostatic Sodium Chloride Injection, USP Product Package Insert, “Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.”

American Regent will credit accounts for all returned product with these lot #s. Those with questions about the return or recall process, please call our Customer Service Department at 1-877-788-3232: Monday thru Friday from 8:30AM to 7:00PM ET.

Hospitals, emergency rooms, infusion centers, clinics and healthcare providers, or patients with product quality complaints, medical or other questions concerning the use of the product or reasons for this recall should contact the Professional Services Department at 1-877-788-3232.

Any adverse reactions experienced with the use of this product should be reported to American Regent, Inc. via email at PV@luitpold.com, by fax to (610) 650-7781 or (610) 650-0170 or by phone at 1-800-734-9236. TO EXPEDITE HANDLING PLEASE DO NOT REPORT ANYTHING OTHER THAN SPECIFIC ADVERSE EVENTS TO THIS EMAIL ADDRESS OR FAX OR PHONE.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online, or regular mail or by fax.
 

    Online:www.fda.gov/medwatch/report.htm1
    Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm2.
    Mail to address on the pre-addressed form.
    Fax: 1-800-FDA-0178
 
Bacteriostatic Sodium Chloride Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).

Source: Luitpold Pharmaceuticals, Inc.

###

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« Last Edit: March 17, 2011, 10:29:35 AM by JustMe » Logged

Eventually they will understand,
Replied the glorious cat
For I will whisper into their hearts
That I am always with them
I just am....forever and ever and ever.
Poem for Cats, author unknown

"A kitten in the animal kingdom is like a rosebud in a garden", author unknown
Mandycat
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« Reply #1 on: March 17, 2011, 03:59:58 PM »

This product would not be used for sub-Q fluids.  It is small vial (30 ml) of sodium chloride that would be used  to reconstitute a powered drug or dilute a stronger concentration of a liquid drug.  The amount needed is drawn up in a needle and injected into the vial of powdered or liquid drug that you are reconstituting or diluting.  This is a multiple dose vial so it can be reused for a few doses used in this way.  The drug in question would only be for injection, not oral drugs.

It is possible, though, that the vet may use this when mixing drugs to use in his office. So, one might want to ask their vet if they use this brand of product as a precaution.   
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JustMe
Administrator
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Posts: 10517


My RB Angels Elvis, 1991-2010, and Twit, 2001-2010


« Reply #2 on: March 17, 2011, 04:25:59 PM »

Thanks, MandyCat!!
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Eventually they will understand,
Replied the glorious cat
For I will whisper into their hearts
That I am always with them
I just am....forever and ever and ever.
Poem for Cats, author unknown

"A kitten in the animal kingdom is like a rosebud in a garden", author unknown
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