Hospira Voluntarily Recalls Certain Lots of Bupivacaine - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Hospira Voluntarily Recalls Certain Lots of Bupivacaine


FDA reported on Sept. 13, 2013 that Hospira had initiated on July 12, 2013 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 Aug. 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). 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 obstetrical procedures.

Both recalls are due to confirmed customer reports of particulate floating and/or embedded in the glass vial, according to FDA. 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). To date, Hospira has not received reports of any adverse events associated with this issue.

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.

Source: FDA

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
26%
Attracting a skilled workforce
29%
Obtaining/maintaining adequate financing
14%
Regulatory compliance
31%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns

Click here