FDAFDA · Food and drugs·Recall number D-1056-2020
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 by: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA.
Published March 18, 2020 · Recall initiated: March 9, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Distributor
- Nationwide in the USA and Puerto Rico.
- Lot
- Lot #: L800951, Exp July 2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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