Recalls / Class II
Class IID-1102-2018
Product
Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0793-19
- Affected lot / code info
- Lot # B0362988-110917, exp. date 10/2018 Lot # B0432265-050318, exp. date 05/2019 Lot # B0450321-061218, exp. date 06/2019 Lot # B0450322-061218, exp. date 05/2019 Lot # B0408652-030718, exp. date 02/2019
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, Indiana, Pennsylvania 15701-3571
Distribution
- Quantity
- 36 bottles of 90 = 3240 tablets
- Distribution pattern
- Product was distributed to three customers in FL and VA.
Timeline
- Recall initiated
- 2018-08-10
- FDA classified
- 2018-08-16
- Posted by FDA
- 2018-08-22
- Terminated
- 2018-10-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1102-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.