Apotex Recalls Olanzapine Tablets Due to Subpotent Drug Levels
Apotex Corp. is recalling Olanzapine Orally Disintegrating Tablets 5 mg because testing showed the drug levels were below specification.
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 the rubric indicates is typically a score of 1 or 2. The hazard is a subpotent drug (quality issue) without reported illnesses, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Apotex Corp. is recalling Olanzapine Orally Disintegrating Tablets 5 mg, 30-count bottles, NDC # 60505-3275-03. The recall involves 5,397 bottles distributed nationwide. The specific lot affected is # KM4951 with an expiration date of 04/15.
The recall was initiated because the product failed to meet quality standards, specifically showing out-of-specification results at the 9-month temperature point. This indicates the medication was subpotent, meaning it contained less of the active drug than required.
Consumers and healthcare providers should check their inventory for this specific NDC, lot number, and expiration date. If the product matches these details, it should be returned to the pharmacy or supplier for disposal or replacement. Patients should consult their healthcare provider for alternative treatment options if they have been using this medication.
The recalled product
- Product
- Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada M9L1T9, Manufactured for Apotex Corp., Weston, Florida 33326, NDC # 60505-3275-03
- Manufacturer
- Apotex Corp.
- Category
- Drug — Antipsychotic
- Hazard
- Affected units
- 5,397
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 # KM4951
- Exp. 04/15
Distribution
Distributed nationwide across the United States.
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