Reported Mar 18, 2020 · Terminated
Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.04mg, and 0.125mg/0.03mg, packaged in 1…
Lupin Pharmaceuticals 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: Lupin Pharmaceuticals Inc. · Harborplace Tower · Baltimore, MD · 21202-6174
Is this the product you have?
- Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.04mg, and 0.125mg/0.03mg, packaged in 1 Wallet of 28 Tablets (NDC 68180-857-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-857-13); Rx Only
- Distributed byLupin Pharmaceuticals, Inc., Baltimore, MD 21202
- Manufactured byLupin Limited, Pithampur (M.P.) - 454775, INDIA
- Lot codes and dates
Lot #: L800951Exp July 2020
- Amount recalled
- 9,897 cartons
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
- PR
Why it was recalled
Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.
This product could cause temporary or reversible health problems — stop using it.
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