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Recall Enforment Report D-1079-2015

Recall Details

Multi event Drug Recall Enforcement Report Class III voluntary initiated by Apotex Inc., originally initiated on 04-07-2015 for the product Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03), b) 100-count blister (NDC 60505-3275-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9 The product was recalled due to subpotent drug. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-1079-201504-07-201505-20-2015Class III23,274 bottles/ blister cartonsOlanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03), b) 100-count blister (NDC 60505-3275-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9Subpotent drugTerminated
D-1081-201504-07-201505-20-2015Class III5,352 bottlesOlanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9Subpotent drugTerminated
D-1080-201504-07-201505-20-2015Class III6,467 bottles/ blister cartonsOlanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03), b) 100-count blister (NDC 60505-3276-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9Subpotent drugTerminated