Olanzapine Tablets recall: Impurity Out of Spec
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma…
Why was Olanzapine Tablets recalled?
Failed Impurities/ Degradation Specifications
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 561180046A1, Exp 8/2020
- Product
- Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma…
- Recalling firm
- Aurobindo Pharma USA Inc.
- Quantity
- 13322 bottles
- Distribution
- U.S.A. Nationwide
- Recall date
- June 24, 2020
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)