Fourteen Health Products Manufactured by Hospira - Incorrect, Outdated or Missing Labelling Information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
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Labelling and Packaging
Audience:
Healthcare Professionals, General Public
Identification number:
RA-56168

Audience

Healthcare professionals working in hospitals, clinics and pharmacies.

Key messages

  • Fourteen (14) health products manufactured by Hospira have incorrect, outdated or missing safety information on the inner/outer labels and/or package insert in certain lots (see Products affected section).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.

           

Issue

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 Two products (Ciprofloxacin Injection USP and Rocuronium Bromide 10 mg/mL for injection) have incorrect or outdated safety information on the product label as well as the package insert. All other products have incorrect, outdated or missing package inserts.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.

Products affected

Products affected
Description DIN List Number
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 0.50% 02305909 01610050
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 09304001 &
09304002
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.

Background information

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
Fax: 1-877-906-0208

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
E-mail: DCVI_UVCEM@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, a Pfizer company

For more information

The 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.