US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jan 26, 2022 (5 years ago)

Terconazole Vaginal Suppositories, 80 mg, 3 Suppositories with Vaginal Applicator, Rx…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

What was recalled

Terconazole Vaginal Suppositories, 80 mg, 3 Suppositories with Vaginal Applicator, Rx only, Manufactured by: Cosette Pharmaceuticals, Inc., 111 Coolidge Street, South Plainfield, NJ 07080. NDC: 0713-0552-73

Recalling firm
Cardinal Healthcare
Origin
OH, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0198-2024

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.