Recalls / Class II
Class IID-1053-2019
Product
Valsartan Tablets 80 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 --- NDC 52343-123-90
- Affected lot / code info
- 471170019A, exp. date 10/31/2019 471180006A, exp. date 03/31/2020 471180007A, exp. date 03/31/2020 471180016A, exp. date 05/31/2020
Why it was recalled
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Recalling firm
- Firm
- Rising Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 250 Pehle Ave Ste 601, N/A, Saddle Brook, New Jersey 07663-5832
Distribution
- Quantity
- 37,410 bottles
- Distribution pattern
- Product was distributed to 6 major distributors who may have further distributed the product throughout the United States.
Timeline
- Recall initiated
- 2019-03-07
- FDA classified
- 2019-03-21
- Posted by FDA
- 2019-03-27
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-1053-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.