Apotex Recalls Subpotent Olanzapine Orally Disintegrating Tablets
Apotex Inc. is voluntarily recalling specific lots of Olanzapine 5 mg orally disintegrating tablets because they contain less active drug than labeled.
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 FDA classified this recall as 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 23,274 bottles and blister cartons of Olanzapine, Orally Disintegrating Tablets, 5 mg. The recall affects specific lots distributed nationwide. The reason for the recall is that the tablets are subpotent, meaning they contain less of the active drug ingredient than stated on the label.
The affected products are identified by the following lot numbers and expiration dates: Lot KL0655 (Exp 04/15), Lot KY2374 (Exp 05/16), Lot KL0656 (Exp 04/15), and Lot KY2371 (Exp 05/16). The products are available in 30-count bottles (NDC 60505-3275-03) and 100-count blisters (NDC 60505-3275-00).
The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers should check their medication for the specific lot numbers listed above and contact their healthcare provider or pharmacist for guidance if they have the affected product.
The recalled product
- 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
- Manufacturer
- Apotex Inc.
- Category
- Drug — Psychiatric Medication
- Hazard
- Affected units
- 23,274
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 (6)
- Lot #: a) KL0655
- Exp 04/15
- KY2374
- Exp 05/16
- b) KL0656
- KY2371
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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