FDA recall D-1397-2012

Product

Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.035 mg, and ferrous fumarate tablets USP, (chewable) 75 mg), 3 Blister Cards, 28 Tablets Each, Rx only, TEVA Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-2090-28 and 0093-2090-58, cartons containing three (3) individual blister packs

Reason for recall

Impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impurity specifications.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2012-05-02

Report date

2012-07-04

Termination date

2013-04-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sellersville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1397-2012