Class II
Terminated
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
- Company
- Remedyrepack Inc.
- Recall Initiated
- August 24, 2018
- Posted
- October 31, 2018
- Recall Number
- D-0093-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2 bottles of 90 tablets (180 tablets)
- Firm Location
- Indiana, PA, United States
Reason for Recall
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Distribution
Product was distributed to a medical facility in South Carolina
Lot / Code Info
Lot # B0438903-052118 70518-1220-00
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