Class II · Moderate risk
Diovan (valsartan)
Failed Dissolution Specifications
Valsartan tablets 160 mg
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Carcinogen impurity detected in API used to manufacture drug product.
Cause type: Nitrosamine impurity
Trace nitrosamine impurities such as NDMA, NDEA or NMBA found above the acceptable daily limit. Nitrosamines are probable human carcinogens that can form during manufacturing or storage. This is the cause behind the large valsartan, losartan and ranitidine (Zantac) recalls. All nitrosamine impurity recalls.
What was recalled
Valsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkins Co, Inc. Grover Beach, CA 93433, NDC 43547-0369-09. Tablet is yellow, capsule-shaped, biconvex, film-coated tablets debossed with 343 on one side and HH on the other side.
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
- H J Harkins Company Inc dba Pharma Pac
- NDC code
- 43547-0369-09
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1022-2018 · 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 H J Harkins Company Inc dba Pharma Pac
All 2018 recalls
Class II · Moderate risk
Acetaminophen and Codeine Phosphate 300/30 mg tablet
cGMP Deviations
Class II · Moderate risk
Acetaminophen 500 mg tablet packaged in a) 30-count bottles
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle
Class II · Moderate risk
Ranitidine
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone…
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
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