FDA-Drug2024-01-03Class II

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

CARDINAL HEALTHCARE
Hazard

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

Sold states
Nationwide USA
Affected count
1 unit
Manufactured in
7200 Cardinal Pl W, Dublin, OH, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0198-2024

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