Apotex Recalls Subpotent Olanzapine Orally Disintegrating Tablets
Apotex Inc. is voluntarily recalling 5,352 bottles of Olanzapine 20 mg tablets because the drug was found to be subpotent.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Apotex Inc. is voluntarily recalling 5,352 bottles of Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle. The recall was initiated because the product was found to be subpotent, meaning it did not contain the full amount of the active ingredient required by the label.
The affected product is identified by Lot # KL0664 and has an expiration date of 04/15. The recall is classified as Class III by the FDA, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. The recall was initiated on April 7, 2015, and was terminated on April 7, 2017.
The product was distributed nationwide. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement, as directed by the recalling firm.
The recalled product
- Product
- Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9
- Manufacturer
- Apotex Inc.
- Category
- Drug — Antipsychotic
- Hazard
- Affected units
- 5,352
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # KL0664
- Exp 04/15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Apotex Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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