Aurobindo Pharma Recalls Olanzapine Tablets Due to Impurity Failures
Aurobindo Pharma USA Inc. is recalling Olanzapine Tablets, USP 2.5 mg, because the product failed impurities and degradation specifications.
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 agency classified this as an FDA Class III recall, which is defined as unlikely to cause adverse health consequences, aligning with the Low severity criterion for documentation or minor specification issues.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling Olanzapine Tablets, USP 2.5 mg, 30-count bottles. The recall is due to the product failing impurities and degradation specifications. The affected product is manufactured for Prasco Laboratories and manufactured by Aurolife Pharma LLC.
The recall involves 13,322 bottles of the medication. The specific lot number is 561180046A1, with an expiration date of 8/2020. The product was distributed nationwide in the United States.
Consumers should check their medication for the specific NDC 66993-680-30 and lot number 561180046A1. If the product matches these details, they should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-680-30
- Manufacturer
- Aurobindo Pharma USA Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 13,322
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 #: 561180046A1
- Exp 8/2020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Aurobindo Pharma USA 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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