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Methotrexate Sodium, USP Injectable Vials by Sandoz US: Recall - Particulate Matter In Vials
AUDIENCE: Pharmacy, Patient, Health Professional
ISSUE: Sandoz is conducting a voluntary nationwide recall to the hospital/user level of two lots of its Methotrexate Sodium, USP, 25 mg/mL, 40 mL vial injectable product in the US, due to the discovery of particulate matter in vials during routine quality examination of retention samples at the manufacturer. Parenteral injection of drug from the affected lots can lead to microembolisation in areas where the particles lodge. Clinical symptoms are not to be expected from these
microemboli and Sandoz is not aware of any reports of related adverse events.
BACKGROUND: Methotrexate is an antimetabolite used in the treatment of neoplastic diseases, severe psoriasis, and rheumatoid arthritis, including polyarticular juvenile rheumatoid arthritis. The lot numbers and expiration dates of the two recalled lots are: CL0996 (expiration date 12/2013) and CJ4948 (expiration date 05/2013). These lots were distributed nationally across the US and to a single foreign country (Poland).
RECOMMENDATION: In the event that a patient experiences an adverse reaction or quality problem involving this product, they should immediately contact their healthcare professional as well as Sandoz to report the finding. The Sandoz Drug Information Direct Line is open at 800-525-2492, 24 hours/day, seven days a week, or reports can be made via email at qa.druginfo@xxxxxxxxxx.
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
Read the MedWatch alert, including a link to the Recall Notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm353266.htm
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@xxxxxxxxxxxxxxx.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
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