D-0198-2024 Class II Terminated
FDA drug recall D-0198-2024 was initiated by CARDINAL HEALTHCARE on Jan 26, 2022 and is designated Class II. Reason for recall: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. The recall status is terminated (terminated Sep 29, 2024). Affected quantity: 1 unit.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 3, 2024
- Initiation Date
- Jan 26, 2022
- Termination Date
- Sep 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
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.
Distribution Pattern
Nationwide USA
Code Information
Batch 1014228A
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0198-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026