Recalls / Class II
Class IID-1146-2018
Product
Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma LTD, Indrad, India 38272, NDC #70518-1220-0
- Affected lot / code info
- 70518-1220-0; Lot #: B0476653-080218; Exp. Date: 08/2019
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
- Type
- Voluntary: Firm initiated
- Address
- 625 Kolter Dr Ste 4, N/A, Indiana, Pennsylvania 15701-3571
Distribution
- Quantity
- 3 bottles of 90 tablets (270 tablets overall)
- Distribution pattern
- South Carolina
Timeline
- Recall initiated
- 2018-08-20
- FDA classified
- 2018-08-28
- Posted by FDA
- 2018-09-05
- Terminated
- 2018-10-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1146-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.