Class II · Moderate risk
Diovan (valsartan)
Failed Dissolution Specifications
Valsartan Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare US, LLC, Cranbury, NJ 08512, USA; NDC 43547-369-09.
Affected NDC
43547-0369-09
Compare with the code on your package — it is the most precise check available.
Drug: Valsartan Category: Blood Pressure Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Valsartan NDC 43547-0369 |
160 mg/1 | Tablet Oral |
Solco Healthcare US, LLC | Rx |
- Recalling firm
- Prinston Pharmaceutical Inc
- NDC code
- 43547-369-09
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0209-2018 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Valsartan recalls
See all
Class II · Moderate risk
Valsartan Tablets USP 40 mg 30 Scored Tablets Rx Only NDC…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Valsartan Tablets 320 mg USP
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Class II · Moderate risk
Valsartan Tablets 160 mg USP
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Class II · Moderate risk
Valsartan Tablets 80 mg USP
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Other recalls by Prinston Pharmaceutical Inc
All 2017 recalls
Class II · Moderate risk
Irbesartan and Hydrochlorothiazide Tablets
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class II · Moderate risk
Irbesartan and Hydrochlorothiazide Tablets
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class II · Moderate risk
Irbesartan and Hydrochlorothiazide Tablets
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class II · Moderate risk
Irbesartan and HydrochlorothiazideTablets
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
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