Notice: Get a jump on 2015 — Pay your 2015 ASA membership dues now!

>

MEETINGS / EVENTS

RSS

January 23 - 25 2015, 12:00 AM - 12:00 AM

ASA PRACTICE MANAGEMENT 2015

February 07 - 08 2015, 12:00 AM - 12:00 AM

ASA Certificate in Business Administration 2015

June 26 - 28 2015, 12:00 AM - 12:00 AM

Annual Perioperative Surgical Home Summit

>

FDA MEDWATCH ALERTS

December 18, 2014

0.9 Percent Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container by Baxter: Recall - Particulate Matter

Summary:

FDA MedWatch Recall - Particulate Matter

November 21, 2014

FDA MedWatch - Respironics California, Esprit V1000 and V200 Ventilators: Class I Recall - Power Failure May Occur

Summary:

FDA MedWatch Respironics California Esprit V1000 and V200 Ventilators Class I Recall

November 21, 2014

FDA MedWatch - Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL by Baxter: Recall - Mislabeled

Summary:

Highly Concentrated Potassium Chloride Injection 10 mEq per 100 mL by Baxter Recall Mislabeled

>

ASA FEATURED PRODUCT

Add this product to your shopping cart

Self-Education and Evaluation (SEE) Program

SKU: 30701-14CE

... Read more »

Single Copies, Member Price: $360

Bupivacaine HCL Injection 0.25% (2.5 MG/ML) and Bupivacaine HCL 0.75% (7.5 MG/ML), 30 ML Single-Dose Vials by Hospira, Inc.: Recall- Presence of Particulate Matter

Monday, September 16, 2013

AUDIENCE: Pharmacy, Anesthesia, Surgery

ISSUE: Hospira, Inc. on July 12, 2013, initiated a voluntary nationwide recall to the user level for one lot of 0.25% Bupivacaine HCl Injection, USP (2.5 mg/mL), 30 mL Single-dose Vial (NDC 0409-1159-02). An expanded recall was issued on August 29, 2013 for one lot of 0.75% Bupivacaine HCl Injection, USP (7.5 mg/mL), 30 mL Single-dose Vial (NDC 0409-1165-02). Both recalls are due to confirmed customer reports of particulate floating and/or embedded in the glass vial. The particulate was identified as stainless steel ranging in size from 542 microns to 1700 microns in lot 18-136-DK (0.25% bupivacaine) and as iron oxide with an average size of 2000 microns in lot 23-338-DK (0.75% bupivacaine).

The administration of an injectable with the presence of foreign particulates may potentially cause thrombophlebitis, bacteremia, sepsis, and/or endocarditis and death may result. Signs and symptoms could include redness, pain, swelling at the site, fever, shortness of breath, tachycardia, nausea and vomiting. Depending on the particle size, if undetected, it could block administration of the diluted drug to the patient, causing a delay in therapy.

BACKGROUND: Bupivacaine is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures.
Both products are packaged 25 units per carton/50 units per case in glass teartop vials. Lot 18-136-DK was distributed August 2012 through September 2012. Lot 23-338-DK was distributed January 2013 through May 2013. Both lots were distributed nationwide to wholesalers/distributors, hospitals and pharmacies.

RECOMMENDATION:  Anyone with an existing inventory should immediately quarantine any affected product and return the product to Stericycle. For contact information regarding the return of products or clinical inquiries please see the Firm Press Release1.

Healthcare professionals 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.htm2
  • Download3 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.

 

« Back to FDA Alerts and Recalls