Teva recall Nortrel (Norethindrone and Ethinyl estradiol) for actives in inert tablets

In a Class 3 recall Teva initiated recall of one lot each of Nortrel and Nortrel 7/7/7. Nortrel and Nortrel 7/7/7 are oral contraceptive tablets with 21 therapeutically active coloured tablets containing the actives norethindrone and ethinyl estradiol and 7 white inert tablets (reminder tablets). The reason for the recall is presence of trace amounts of ethinyl estradiol in the white inert tablets at or below 10% of the established acceptable daily intake (ADE). The reason for presence of actives could be possibility of the discoloured (blue) active tablets mixed in with the white inert ‘reminder’ tablets. The ADE for ethinyl estradiol is quite low at 2.0 mcg/tablet (or 0.002mg/tablet). The inert ‘reminder’ tablets are not supposed to contain any actives.

Nortrell (NDC 0555-9008-67) has 21 light yellow coloured active tables  – Norethindrone (0.5mg) and Ethinyl estradiol (0.035mg) along with 7 white inert tablets.

Nortrel 7/7/7 (NDC 0555-9012-58 ) has 21 active tablets – 7 light yellow Norethindrone (0.5mg) and Ethinyl estradiol (0.035mg) tablets, 7 blue coloured Norethindrone (0.75mg) and Ethinyl estradiol (0.035mg) tablets, 7 peach coloured Norethindrone (1.0mg) and Ethinyl estradiol (0.035mg) tablets.

A recall notification of Teva claims “trace amounts of estradiol API in the reminder tablets of the affected lots are not expected to cause additional side effects or adverse health consequences”

Enforcement Report (Recall Notification).

Recall Alert