Recall: D-0198-2024

Class II - Potentially Harmful

Class IIClassification

2022-01-26Initiated

TerminatedStatus

CARDINAL HEALTHCAREFirm

Product

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

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

Distribution

Nationwide USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.