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Marcaine 0.5%, Marcaine E 0.25% and 0.5% - EXPANDED Recall of 5 additional lots due to the possibility of embedded particles in the glass vial - Notice to hospitals
- Starting date:
- November 30, 2013
- Posting date:
- November 30, 2013
- Type of communication:
- Dear Healthcare Professional Letter
- Subcategory:
- Drugs
- Source of recall:
- Health Canada
- Issue:
- Important Safety Information, Quality
- Identification number:
- RA-37045
This is duplicated text of a letter from Hospira Healthcare Corporation. Contact the company for a copy of any references, attachments or enclosures.
UPDATED NOTICE TO HOSPITALS: EXPANDED RECALL of additional lots of Marcaine - Health Canada Endorsed Important Safety Information on Marcaine (bupivacaine hydrochloride injection USP) and Marcaine E (bupivacaine hydrochloride and epinephrine injection USP)
Novembre 30, 2013
Dear Chief of Medical Staff and Director of Pharmacy
Please distribute to relevant Departments (Oncology, Pharmacy, Geriatrics, Internal Medicine, Nursing, Paediatrics, Intensive Care Unit, Coronary Care, Emergency Department, Surgery, Recovery Room, Anaesthesiology and/or other Departments as required), and other involved professional staff and post this Notice in the relevant areas of your institution.
Subject: EXPANDED Recall of 5 additional lots of Marcaine 0.5% (bupivacaine hydrochloride injection USP) and Marcaine E 0.25% and 0.5% (bupivacaine hydrochloride and epinephrine injection USP) due to the possibility of embedded particles in the glass vial (DINs and Lots listed below).
Hospira Healthcare Corporation, in consultation with Health Canada, would like to inform you of an expanded recall of 5 additional lots of Marcaine (bupivacaine hydrochloride injection USP) and Marcaine E (bupivacaine hydrochloride and epinephrine injection USP) listed below due to the possibility of embedded particles in the glass vial.
“Marcaine and Marcaine E are indicated for the production of local or regional anaesthesia and analgesia with the following procedures: local infiltration procedures, peripheral nerve blocks, retrobulbar blocks and caudal, epidural and subarachnoid (spinal) blocks.” (Canadian Product Monograph, Marcaine (bupivacaine hydrochloride injection USP) April 6, 2011; page 4.)
These lots were distributed between June 2013 and November 2013.
- There is a possibility for vial defects and embedded particulate matter in glass vials of Marcaine 0.5%, Marcaine E 0.25% and Marcaine E 0.5%.
- As with all injectable products, healthcare professionals should visually inspect the vials for defects and not use if any are observed.
- Vials from the affected lots should not be used and should be returned to Hospira.
Hospira has not received any reports of adverse events associated with these lots of Marcaine from its customers.
Hospira’s investigation is on-going to determine the root cause and corrective and preventive actions.
| Product | DIN | List Number | Lot Number | Expiry Date |
|---|---|---|---|---|
| Marcaine E 0.25% 50 mg/20 mL | 02241915 | 02080020 | 28030DD | 2014/10/01 |
| Marcaine E 0.25% 50 mg/20 mL | 02241915 | 02080020 | 30095DD | 2014/12/01 |
| Marcaine E 0.50% 100 mg/20 mL | 02241916 | 02083020 | 28125DD | 2014/10/01 |
| Marcaine 0.50% 100 mg/20 mL | 02241919 | 02077020 | 28150DD | 2015/04/01 |
| Marcaine 0.50% 100 mg/20 mL | 02241919 | 02077020 | 29100DD | 2015/05/01 |
Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-market adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious adverse reaction or other serious or unexpected adverse reactions in patients receiving Marcaine (bupivacaine hydrochloride injection) or Marcaine E (bupivacaine hydrochloride and epinephrine injection) should be reported to Hospira Healthcare Corporation or Health Canada at the following addresses:
Hospira Healthcare Corporation
1111 Dr.-Frederik-Philips, Suite 600
Saint-Laurent (Québec) H4M 2X6
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 1-866-488-6088 Option 6
Fax: 1-877-906-0208
ProductcomplaintsCA@hospira.com
To correct your mailing address or fax number, contact: Hospira Healthcare Corporation.
You can report any suspected adverse reactions associated with the use of health products to Health Canada by:
- Calling toll-free at 1-866-234-2345, o
- Visiting MedEffect Canada’s Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.
For other health product inquiries related to this communication, please contact Health Canada at:
Health Products and Food Branch Inspectorate (HPFBI)
E-mail: DCVIU_UVECM@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 1-613-946-5636.
Sincerely,
original signed by
Rania Al-Ammar
Regional Director, Commercial Quality
Hospira Healthcare Corporation