Apotex Recalls Subpotent Olanzapine Orally Disintegrating Tablets
Apotex Inc. is voluntarily recalling 6,467 units of Olanzapine 10 mg orally disintegrating tablets because the drug is subpotent.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is a subpotent drug, which is a quality issue rather than a contamination or acute safety defect.
Plain-English summary
Apotex Inc. is voluntarily recalling Olanzapine, Orally Disintegrating Tablets, 10 mg. The recall affects 30-count bottles (NDC 60505-3276-03) and 100-count blisters (NDC 60505-3276-00). The specific lots involved are KY2389 and KY2388, both with an expiration date of 05/16.
The reason for the recall is that the drug is subpotent, meaning it does not contain the full amount of the active ingredient required. A total of 6,467 bottles and blister cartons were distributed nationwide.
Consumers and healthcare providers should check their inventory for the specific NDCs and lot numbers listed above. If the product is found, it should be returned to the pharmacy or supplier for a refund or replacement. The recall was initiated by the firm and has been terminated.
The recalled product
- Product
- Olanzapine, 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 1T9
- Manufacturer
- Apotex Inc.
- Category
- Drug — Antipsychotic
- Hazard
- Affected units
- 6,467
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 (3)
- Lot #: a) KY2389
- Exp 05/16
- b) KY2388
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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