UPDATED 10/21/2013 with related product recall information
Hospira announced a voluntary nationwide recall to the user level for one lot of 0.25% Marcaine (Bupivacaine HCl Injection, USP), 75 mg/30 mL, Single-dose Vial – Preservative Free (NDC 0409-1559-30), Lot 25-220-DD. The recall is due to a confirmed customer report of discolored solution with visible particles inside the glass vial as well as embedded in the glass. See firm's press release below for further information.
AUDIENCE: Health Professional, Risk Manager
ISSUE: Hospira, Inc. announced it has initiated a voluntary nationwide recall of one lot of 1% Lidocaine HCI Injection, USP, 10 mg/mL, 20 mL Multiple-dose Fliptop Vial, NDC 0409-4276-01 Lot 25-090-DK (the lot number may be followed by 01 or 02). This action is due to one confirmed customer report of visible particulate, identified in the primary container, in the form of dark red/black particles. The particulate was identified as oxidized stainless steel. Depending on the particle size, if undetected, it could block administration of the drug to the patient, causing a delay in therapy. Impact to the patient would depend on the time it would take to obtain a new vial, the condition being treated and the patient’s status.
BACKGROUND: The recall is being conducted as a precautionary measure. The root cause has not been determined and is under investigation. Hospira informed customers of the issue in a letter dated Sept. 16, 2013. This lot was distributed March 2013 through June 2013.
RECOMMENDATION: Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-866-364-8812 between the hours of 8am to 5pm ET, Monday through Friday, to arrange for the return of the product. Replacement product from other lots is available.
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
[10/04/2013 - Firm Press Release]
[10/17/2013 - Firm Press Release]