D-0093-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 31, 2018
- Initiation Date
- August 24, 2018
- Termination Date
- October 29, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 bottles of 90 tablets (180 tablets)
Product Description
Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30 Repackaged NDC 70518-1220-00
Reason for Recall
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Distribution Pattern
Product was distributed to a medical facility in South Carolina
Code Information
Lot # B0438903-052118 70518-1220-00