Why it was recalled
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Product description
My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454 775, INDIA, UPC 3 68180 85212 4.
Lot numbers, UPCs & expiration codes
Lot #: L700329, Exp 08/19; L700670, Exp 11/19
Where it was sold
Nationwide in the USA
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-0838-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 17, 2018
- FDA report date
- May 30, 2018
- Quantity
- 43,640 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0838-2018, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 80097
- Address
- 111 S Calvert St Fl 21ST
- Code information
- Lot #: L700329, Exp 08/19; L700670, Exp 11/19
- Postal code
- 21202-6174
- Report date
- May 30, 2018
- Product type
- Drugs
- Recall number
- D-0838-2018
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 43,640 cartons
- Termination date
- May 1, 2019
- Reason for recall
- Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454 775, INDIA, UPC 3 68180 85212 4.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- May 17, 2018
- Initial firm notification
- Letter
- Center classification date
- May 31, 2018