PlainRecalls
FDA Drug Low Class III Ongoing

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

Reported: February 21, 2024 Initiated: January 25, 2024 #D-0321-2024

Product Description

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.

Details

Units Affected
12,916 cartons
Distribution
nationwide
Location
Parsippany, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Teva Pharmaceuticals USA, Inc. Units affected: 12,916 cartons.
Why was this product recalled?
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 21, 2024. Severity: Low. Recall number: D-0321-2024.