Recalls / Class II
Class IID-1052-2019
Product
Valsartan Tablets 40 mg USP, 30 tablet bottles, Rx, Only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ, Manufactured by: Aurolife Pharma LLC, Dayton, NJ ---- NDC 52343-122-30
- Affected lot / code info
- 470170038A, exp. date 10/31/2019 470180010A, exp. date 02/29/2019 470180012A, exp. date 03/31/2020
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
- 30,530 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-1052-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.