Reported Feb 8, 2017 · Terminated
Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-01) bottles, Rx Only,…
Dr. Reddy's Laboratories, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Dr. Reddy's Laboratories, Inc. · 107 College Rd E · Princeton, NJ · 08540-6623
Is this the product you have?
- Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-01) bottles, Rx Only, Mfd
- byDr. Reddy's Laboratories, Bachupally 500 090 India
- Lot codes and dates
a) 30 count C500228exp 12/2016C500848 and C500850exp 01/2017 C503651 and C503653exp 04/2017b) 100 count C500226exp 12/2016C500848C500850exp 01/2017C503649 and C503653exp 04/2017
- Amount recalled
- a) 38,832 and b) 5,064 bottles
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications; 18 month stability time point
This product could cause temporary or reversible health problems — stop using it.
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