Recalls / Class II
Class IID-1020-2018
Product
Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
- Affected lot / code info
- Lot # B0318652-070617; Exp. 07/18
Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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
- 4 HDPE 90-count bottles (360 tablets)
- Distribution pattern
- Product was distributed to 3 medical facilities in Florida.
Timeline
- Recall initiated
- 2018-07-17
- FDA classified
- 2018-07-31
- Posted by FDA
- 2018-08-08
- Terminated
- 2018-10-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1020-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.