FDA Recall D-1093-2017
Lupin Limited (Unit 1) · Pithampur, N/A
Class I — life-threatening Terminated 744 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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
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.
Recall record
- Recall number
D-1093-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2017-05-16
- Classified by FDA Center
- 2017-08-15
- FDA published
- 2017-08-23
- Terminated
- 2019-05-30
- Recalling firm
- Lupin Limited (Unit 1)
- Firm location
- Pithampur, N/A, India