Why it was recalled
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Product description
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
Lot numbers, UPCs & expiration codes
471170019A, exp. date 10/31/2019 471180006A, exp. date 03/31/2020 471180007A, exp. date 03/31/2020 471180016A, exp. date 05/31/2020
Where it was sold
Product was distributed to 6 major distributors who may have further distributed the product throughout the United States.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1053-2019
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 7, 2019
- FDA report date
- Mar 27, 2019
- Quantity
- 37,410 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Rising Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1053-2019, exactly as published.
Show all FDA fields
- City
- Saddle Brook
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 82337
- Address
- 250 Pehle Ave Ste 601
- Code information
- 471170019A, exp. date 10/31/2019 471180006A, exp. date 03/31/2020 471180007A, exp. date 03/31/2020 471180016A, exp. date 05/31/2020
- Postal code
- 07663-5832
- Report date
- Mar 27, 2019
- Product type
- Drugs
- Recall number
- D-1053-2019
- Classification
- Class II
- Recalling firm
- Rising Pharmaceuticals, Inc.
- Product quantity
- 37,410 bottles
- Reason for recall
- CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Product was distributed to 6 major distributors who may have further distributed the product throughout the United States.
- Recall initiation date
- Mar 7, 2019
- Initial firm notification
- Letter
- Center classification date
- Mar 21, 2019