Drug 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
D-1093-2017
Product summary
- Event
- Event 77323
- Status
- Terminated
- Classification
- Class I
- Quantity
- 24,652 tablets
- Official record key
drug-enforcement:D-1093-2017
Official wording
Reason: 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.
Code information: Batch Number L600518; Exp. 05/18
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
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.