Recalls / Class II
Class IID-1054-2019
Product
Valsartan Tablets 160 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 52343-124-90
- Affected lot / code info
- 472180005B, exp. date 02/29/2020 472180011A, exp. date 04/30/2020 472180012A, exp. date 04/30/2020
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
- 35,281 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-1054-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.