Torrent Pharma Recalls Olanzapine Tablets Due to Defective Container
Torrent Pharma Inc is recalling 18,721 bottles of Olanzapine Tablets 10 mg because the packaging filler material was not approved.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 II and is described as a precautionary measure due to a packaging defect, which aligns with the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Torrent Pharma Inc is recalling 18,721 bottles of Olanzapine Tablets, USP, 10 mg, Rx Only. The affected product is identified by Lot # BS392004A with an expiration date of 09/2014. The product was distributed nationwide.
The recall is a precautionary measure due to a defective container. The product was re-packaged in the U.S. using a filler material that removes or blocks less moisture than what is approved in the application.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Olanzapine Tablets, USP, 10 mg, Rx Only, 30 tablets per bottle, Mfd for: Prasco Laboratories, Mason OH, 45040, USA, Mfd by: Torrent Pharmaceuticals Ltd., Indrad-382 721, Dist. Mehsana India, NDC 66993-463-30
- Manufacturer
- Torrent Pharma Inc
- Category
- Drug — Prescription Medication
- Affected units
- 18,721
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 #: BS392004A
- Exp: 09/2014
Distribution
Distributed nationwide across the United States.
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