Recalls / Class II
Class IID-0093-2019
Product
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
- Affected lot / code info
- Lot # B0438903-052118 70518-1220-00
Why it was recalled
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Recalling firm
- Firm
- RemedyRepack Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 625 Kolter Dr Ste 4, N/A, Indiana, Pennsylvania 15701-3571
Distribution
- Quantity
- 2 bottles of 90 tablets (180 tablets)
- Distribution pattern
- Product was distributed to a medical facility in South Carolina
Timeline
- Recall initiated
- 2018-08-24
- FDA classified
- 2018-10-24
- Posted by FDA
- 2018-10-31
- Terminated
- 2018-10-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0093-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.