Why it was recalled
Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: L800951, Exp July 2020
Where it was sold
Nationwide in the USA and Puerto Rico.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1056-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 9, 2020
- FDA report date
- Mar 18, 2020
- Quantity
- 9,897 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1056-2020, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 85169
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- Lot #: L800951, Exp July 2020
- Postal code
- 21202-6174
- Report date
- Mar 18, 2020
- Product type
- Drugs
- Recall number
- D-1056-2020
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 9,897 cartons
- Termination date
- May 25, 2021
- Reason for recall
- Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
- Recall initiation date
- Mar 9, 2020
- Initial firm notification
- Letter
- Center classification date
- Mar 24, 2020