FDA recall D-1093-2017

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-05-16

Report date

2017-08-23

Termination date

2019-05-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pithampur, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1093-2017