Reported Jun 24, 2020 · Terminated
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA,…
Aurobindo Pharma USA Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aurobindo Pharma USA Inc. · 279 Princeton Hightstown Rd · East Windsor, NJ · 08520-1401
Is this the product you have?
- Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only
- Manufactured forPrasco Laboratories Mason, OH 45040 USA
- Manufactured by
Aurolife Pharma LLC DaytonNJ 08810NDC 66993-680-30
- Lot codes and dates
Lot #: 561180046A1Exp 8/2020
- Amount recalled
- 13322 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/ Degradation Specifications
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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