D-1093-2017 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 23, 2017
- Initiation Date
- May 16, 2017
- Termination Date
- May 30, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24,652 tablets
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
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.
Distribution Pattern
Nationwide
Code Information
Batch Number L600518; Exp. 05/18