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
Reported: January 3, 2024 Initiated: January 26, 2022 #D-0198-2024
Product Description
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
Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Details
- Recalling Firm
- CARDINAL HEALTHCARE
- Units Affected
- 1 unit
- Distribution
- Nationwide USA
- Location
- Dublin, OH
Frequently Asked Questions
What product 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. Recalled by CARDINAL HEALTHCARE. Units affected: 1 unit.
Why was this product recalled? ▼
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 3, 2024. Severity: Moderate. Recall number: D-0198-2024.
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