Recalls / Class II
Class IID-1100-2018
Product
Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0791-19
- Affected lot / code info
- Lot # B0335344-081717, exp. date 08/2018 Lot # B0363364-110917, exp. date 11/2018 Lot # B0391225-012218, exp. date 01/2019 Lot # B0408458-030618, exp. date 03/2019 Lot # B0384871-010318, exp. date 01/2019 Lot # B0436862-051518, exp. date 05/2019
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
- 9 bottles of 90 = 810 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-1100-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.