Home / Recalls / Rising Pharmaceuticals, Inc. / D-1054-2019

D-1054-2019 Class II Ongoing

Recalled by Rising Pharmaceuticals, Inc. — Saddle Brook, NJ

Recall Details

Product Type
Drugs
Report Date
March 27, 2019
Initiation Date
March 7, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
35,281 bottles

Product Description

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

Reason for Recall

CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products

Distribution Pattern

Product was distributed to 6 major distributors who may have further distributed the product throughout the United States.

Code Information

472180005B, exp. date 02/29/2020 472180011A, exp. date 04/30/2020 472180012A, exp. date 04/30/2020

Other recalls by Rising Pharmaceuticals, Inc.

  • D-0348-2023 Class II — Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by: Ri (February 15, 2023)
  • D-0573-2022 Class II — Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Onl (February 7, 2022)
  • D-0005-2022 Class II — Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: (September 2, 2021)
  • D-1367-2020 Class III — Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For Topi (November 15, 2019)
  • D-1368-2020 Class III — Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topical (November 15, 2019)
  • D-1055-2019 Class II — Valsartan Tablets 320 mg USP, 90 tablet bottles, Distributed by: Acetris Health, (March 7, 2019)
  • D-1053-2019 Class II — Valsartan Tablets 80 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetri (March 7, 2019)
  • D-1052-2019 Class II — Valsartan Tablets 40 mg USP, 30 tablet bottles, Rx, Only, Distributed by: Acetri (March 7, 2019)