FDA recall D-0321-2024

Product

Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9008-67

Reason for recall

Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.

Distribution

nationwide

Key facts

Status

Ongoing

Initiation date

2024-01-25

Report date

2024-02-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0321-2024