Class II · Moderate risk
Valsartan tablets 160 mg
Carcinogen impurity detected in API used to manufacture drug product.
National Drug Code
Is NDC 43547-0369-09 recalled?
Valsartan · 90 TABLET in 1 BOTTLE (43547-369-09)
Yes — this exact package was recalled
3 FDA recalls name the code 43547-0369-09 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
1 of these recalls is still ongoing.
- Active ingredient
- valsartan
- Strength
- VALSARTAN 160 mg/1
- Form
- Tablet · Oral
- Labeler
- Solco Healthcare US, LLC
- Type
- Human Prescription Drug
- Product code
- 43547-0369
Recalls naming this package
Class II · Moderate risk
Solco Healthcare US Valsartan
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan Tablets
Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
- 43547-0331 Irbesartan and Hydrochlorothiazide 3
- 43547-0330 Irbesartan and Hydrochlorothiazide 2
- 43547-0275 donepezil hydrochloride 1
- 43547-0276 donepezil hydrochloride 1
- 43547-0311 Valsartan and Hydrochlorothiazide 1
- 43547-0312 Valsartan and Hydrochlorothiazide 1
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