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
Reported: October 31, 2018 Initiated: August 24, 2018 #D-0093-2019
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.
Details
- Recalling Firm
- RemedyRepack Inc.
- Units Affected
- 2 bottles of 90 tablets (180 tablets)
- Distribution
- Product was distributed to a medical facility in South Carolina
- Location
- Indiana, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by RemedyRepack Inc.. Units affected: 2 bottles of 90 tablets (180 tablets).
Why was this product recalled? ▼
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 31, 2018. Severity: Moderate. Recall number: D-0093-2019.
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