Recalls / Class II
Class IID-1056-2020
Product
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.
- Affected lot / code info
- Lot #: L800951, Exp July 2020
Why it was recalled
Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 9,897 cartons
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
Timeline
- Recall initiated
- 2020-03-09
- FDA classified
- 2020-03-24
- Posted by FDA
- 2020-03-18
- Terminated
- 2021-05-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1056-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.