Fourteen Health Products Manufactured by Hospira - Incorrect, Outdated or Missing Labelling Information
- Starting date:
- December 10, 2015
- Posting date:
- December 11, 2015
- Type of communication:
- Dear Healthcare Professional Letter
- Source of recall:
- Health Canada
- Labelling and Packaging
- Healthcare Professionals, General Public
- Identification number:
Healthcare professionals working in hospitals, clinics and pharmacies.
- Fourteen (14) health products manufactured by Hospira have incorrect, outdated or missing safety information on the inner/outer labels and/or package insert in certain lots (see Products affected section).
- Without this information, there may be an increased risk to the patient that may result in significant patient harm requiring medical intervention.
- The labels on the products and/or the package inserts will be corrected as soon as possible to include the most updated information approved by Health Canada.
- For a full description of information missing from the inner/outer labels and/or package insert, refer to appendices posted on Hospira’s website.
- Healthcare professionals are requested to consult the approved Canadian Product Monograph on Health Canada’s website which has the most up-to-date information.
The inner/outer labels and/or package insert of fourteen (14) health products manufactured by Hospira do not reflect the most up-to-date information and warnings (see Products affected section). Two products (Ciprofloxacin Injection USP and Rocuronium Bromide 10 mg/mL for injection) have incorrect or outdated safety information on the product label as well as the package insert. All other products have incorrect, outdated or missing package inserts. The missing information and/or warnings may increase the risk to patients and may result in significant patient harm requiring medical intervention.
|Ceftriaxone for Injection USP 1g||02292874||50443|
|Ceftriaxone for Injection USP 2g||02292882||50444|
|Ciprofloxacin Injection 200 mg in Dextrose 5%||02301903||04777001|
|Ciprofloxacin Injection 400 mg in Dextrose 5%||02301903||04777201|
|Cytarabine Injection USP 100 mg/mL||02126656||1992C001|
|Cytarabine Injection USP 2g/20 mL||02126656||2016A001|
|Epirubicin Hydrochloride for Injection 50 mg/25 mL||02264927||2415A002|
|Epirubicin Hydrochloride for Injection 200 mg/100 mL||02264927||2417A002|
|Hydromorphone Hydrochloride Injection USP, 10 mg/mL, 1 mL vial||02382636||02634001|
|Hydromorphone Hydrochloride Injection USP, 10 mg/mL, 5 mL vial||02382636||02634002|
|Hydromorphone Hydrochloride Injection USP, 10 mg/mL, 50 mL vial||02382636||02634003|
|Irinotecan Hydrochloride Injection USP 100 mg/5 mL||02258218||3775A001|
|Irinotecan Hydrochloride Injection USP 500 mg/25 mL||02258218||3780A001|
|Irinotecan Hydrochloride Injection USP 40 mg/2 mL||02258218||3770A001|
|Levofloxacin 5 mg/mL in 5% Dextrose Injection USP||02314932||00528004|
|Levofloxacin 5 mg/mL in 5% Dextrose Injection USP||02314932||00528005|
|Levofloxacin 5 mg/mL in 5% Dextrose Injection USP||02314932||00528006|
|Marcaine 2.5 mg/mL||02241918||01559010|
|Marcaine 0.25 %||02305895||01587050|
|Marcaine 2.5 mg/mL||02241918||02073020|
|Marcaine E 2.5 mg/mL||02241915||02080020|
|Marcaine 5 mg/mL||02241919||01560010|
|Marcaine 5 mg/mL||02241919||02077020|
|Marcaine 7.5 mg/mL||02241917||02079020|
|Marcaine E 5 mg/mL||02241916||02083020|
|Marcaine Spinal 7.5 mg/mL||02241914||01761002|
|Methotrexate Injection USP 20 mg/2 mL||02182947||4407C001|
|Methotrexate Injection USP 50 mg/2 mL||02182955||4412C001|
|Methotrexate Injection USP 50 mg/2 mL||02182777||4437C001|
|Methotrexate Injection USP 500 mg/20 mL||02182971||4427A001|
|Methotrexate Injection USP 500 mg/20 mL||02182777||4442A001|
|Methotrexate Injection USP 2.5g/100 mL||02182971||4445A001|
|Methotrexate Injection USP 1g/40 mL||02182971||4457A001|
|Metronidazole 500 mg injection USP||00649074||07811853|
|Metronidazole 500 mg injection USP||00649074||07811888|
|Paclitaxel for Injection 30 mg/5 mL||02296624||6840A001|
|Paclitaxel for Injection 300 mg/50 mL||02296624||6843A001|
|Paclitaxel for Injection 100 mg/16.7 mL||02296624||6841A001|
|Rocuronium Bromide 10 mg/mL for injection||02318121||09559001|
|Ropivacaine Hydrochloride Injection 150 mg/30 mL||02347822||09301030|
|Ropivacaine Hydrochloride Injection 100 mg/10 mL||02347830||09303010|
|Ropivacaine Hydrochloride Injection 200 mg/20 mL||02347830||09303020|
|Ropivacaine Hydrochloride Injection 2 mg/mL||02403285||
|Zoledronic Acid 4 mg/5 mL for Injection||02421550||04215001|
For a full description of information missing from the inner/outer labels and/or package insert, refer to appendices posted on Hospira’s website.
To date, there have been no adverse events reported to be associated with this issue, except for Rocuronium Bromide Injection, for which two out of three reported cases may have been potentially due to outdated information. There are no concerns with the quality of these products.
The labels on the products and/or the package inserts will be corrected as soon as possible to include the most updated information approved by Health Canada.
Who is affected
Information for consumers
Consumers using any of the health products affected by this issue should contact their healthcare professional for more information.
Information for health care professionals
Healthcare professionals should refer to the approved Canadian Product Monograph on Health Canada’s website for the most up-to-date information on each of these health products.
Action taken by Health Canada
Health Canada is communicating this important safety information to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. Health Canada is also monitoring the company’s implementation of necessary corrective and preventative actions.
Report health or safety concerns
Managing marketed health product-related side effects depends on healthcare professionals and consumers reporting them. Any case of serious or unexpected side effects in patients receiving health products mentioned in this communication should be reported to Hospira HealthCare Corporation or Health Canada.
Hospira Healthcare Corporation, a Pfizer Company
2600 Alfred-Nobel Blvd, Suite 500
Saint-Laurent (Quebec), H4S 0A9
Telephone: 1-866-488-6088, Option 6
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; or
- 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, contact Health Canada at:
Health Product and Food Branch Inspectorate
Original signed by
Regional Director, Commercial Quality
Hospira Healthcare Corporation, a Pfizer company
For more informationThe manufacturer advised Health Canada of the risk associated with this health product. Health Canada supports the actions taken by the manufacturer and as such a risk assessment was not required and a Summary Safety Review was not prepared.
- Date modified: