Hormone Pellets Recalled Over Sterility Concerns

Qualgen LLC is recalling several strengths of estradiol pellets due to sterility concerns, according to the November 14, 2018, US Food and Drug Administration (FDA) Enforcement Report.

The recall includes the following estradiol products, which were distributed nationwide:

• estradiol 10-mg pellets in 1-count (NDC 69761-010-01), 6-count (NDC 69761-010-06), 12-count (NDC 69761-010-12), and 30-count (NDC 69761-010-30) vials from lots C262 (beyond-use date [BUD] 12/20/18), D067 (BUD 3/21/19), and D072 (BUD 3/28/19);
• estradiol 12.5-mg pellets in 1-count (NDC 69761-012-01), 6-count (NDC 69761-012-06), 12-count (NDC 69761-012-12), and 30-count (NDC 69761-012-30) vials from lot C236 (BUD 11/13/18);
• estradiol 15-mg pellets in 1-count (NDC 69761-015-01), 6-count (NDC 69761-015-06), 12-count (NDC 69761-015-12), and 30-count (NDC 69761-015-30) vials from lots C253 (BUD 12/12/18) and D016 (BUD 1/18/19);
• estradiol 18-mg pellets in 1-count (NDC 69761-018-01), 6 count (NDC 69761-018-06), 12 count (NDC 69761-018-12), and 30 count (NDC 69761-018-30) vials from lot C255 (BUD 12/13/18); and
• estradiol 25-mg pellets in 1-count (NDC 69761-025-01), 6-count (NDC 69761-025-06), 12-count (NDC 69761-025-12), and 30-count (NDC 69761-025-30) vials from lot C238 (BUD 11/14/18).

Qualgen voluntarily initiated the recall October 17, 2018. On November 7, 2018, the FDA designated the recall Class II. Use of the products affected by Class II recalls could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Estradiol pellets are used to treat estradiol imbalance or ease the effects of menopause.

—Jolynn Tumolo

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