Jubilant Recalls Subpotent Olanzapine Orally Disintegrating Tablets Nationwide
Jubilant Cadista Pharmaceuticals is voluntarily recalling 23,616 blister packs of Olanzapine Orally Disintegrating Tablets, 5 mg, because the product 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 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
Jubilant Cadista Pharmaceuticals, Inc. is voluntarily recalling 23,616 blister packs of Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose). The product is prescription-only and was manufactured by Jubilant Generics, Ltd., in Roorkee, India. The specific lot affected is # AE119001A with an expiration date of 01/2021.
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 FDA has classified this recall as Class III, which indicates that use of or exposure to the product is not likely to cause adverse health consequences.
The product was distributed nationwide. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. Those who have this product should stop using it and contact their pharmacist or healthcare provider for guidance on obtaining a replacement.
The recalled product
- Product
- Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) blister pack, Rx only, Manufactured by: Jubilant Generics, Ltd., Roorkee, India, Marketed by: Jubilant Cardista Pharmaceuticals, Inc., Salisbury, MD NDC 59746-0306-32
- Manufacturer
- Jubilant Cadista Pharmaceuticals, Inc.
- Category
- Drug — Antipsychotic
- Hazard
- Affected units
- 23,616
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 # AE119001A
- exp. date 01/2021
Distribution
Distributed nationwide across the United States.
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