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Health Canada Health products

Tacrolimus and the Risk of Graft Rejection due to Medication Errors: Inadvertent Switching between Different Oral Formulations

Issued July 22, 2019
Issue
Graft rejection and other adverse reactions have been reported as a consequence of medication errors where patients received the wrong formulation of oral tacrolimus. Products affected Brand/Product Name Strength Manufacturer Immediate Release Capsule ACH-TACROLIMUS 0.5mg, 1mg, and 5mg Accord Healthcare Inc. APO-TACROLIMUS 0.5mg, 1mg, and 5mg Apotex Inc. JAMP-TACROLIMUS 0.5mg, 1mg, and 5mg Jamp Pharma Corporation PROGRAF ® 0.5mg, 1mg, and 5mg Astellas Pharma Canada, Inc. RAN-TACROLIMUS 5mg Sun Pharma Canada Inc. (formerly Ranbaxy Pharmaceuticals Canada Inc.) SANDOZ TACROLIMUS 0.5mg, 1mg, and 5mg Sandoz Canada Inc. Extended Release Capsule ADVAGRAF ® 0.5 mg, 1 mg, 3 mg, and 5 mg Astellas Pharma Canada, Inc. Prolonged Release Tablet ENVARSUS PA TM 0.75 mg, 1 mg, and 4 mg Endo Ventures Ltd. Importer: Paladin Labs Inc.
Hazard description
Product safety