Why it was recalled
Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package.
Product description
Mibelas 24 Fe (Norethindrone acetate and Ethinyl estradiol 1 mg/0.02 mg chewable and ferrous Fumarate 75 mg) Tablets, wallet of 28 tablets (NDC 68180-911-11), Carton of 3 wallets (NDC 68180-911-13), Rx Only, Manufactured by: Lupin Limited, India, Distributed by Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202
Lot numbers, UPCs & expiration codes
Batch Number L600518; Exp. 05/18
Where it was sold
Nationwide
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-1093-2017
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 16, 2017
- FDA report date
- Aug 23, 2017
- Quantity
- 24,652 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Limited (Unit 1)
Original FDA data
Every field from FDA enforcement report D-1093-2017, exactly as published.
Show all FDA fields
- City
- Pithampur
- Status
- Terminated
- Country
- India
- Event ID
- 77323
- Address
- Unit 1, Plot 2, SEZ, Phase II,
- Address (line 2)
- Misc Zone Apparel Park, Dist. Dhar
- Code information
- Batch Number L600518; Exp. 05/18
- Report date
- Aug 23, 2017
- Product type
- Drugs
- Recall number
- D-1093-2017
- Classification
- Class I
- Recalling firm
- Lupin Limited (Unit 1)
- Product quantity
- 24,652 tablets
- Termination date
- May 30, 2019
- Reason for recall
- Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Mibelas 24 Fe (Norethindrone acetate and Ethinyl estradiol 1 mg/0.02 mg chewable and ferrous Fumarate 75 mg) Tablets, wallet of 28 tablets (NDC 68180-911-11), Carton of 3 wallets (NDC 68180-911-13), Rx Only, Manufactured by: Lupin Limited, India, Distributed by Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202
- Distribution pattern
- Nationwide
- Recall initiation date
- May 16, 2017
- Initial firm notification
- Letter
- Center classification date
- Aug 15, 2017