Class II · Moderate risk
Valsartan and Hydrochlorothiazide Tablets
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
National Drug Code
Is NDC 0378-6322-05 recalled?
Valsartan and Hydrochlorothiazide
Yes — this exact package was recalled
1 FDA recall names the code 0378-6322-05 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 and hydrochlorothiazide
- Strength
- VALSARTAN 160 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1
- Form
- Tablet, Film Coated · Oral
- Labeler
- Mylan Pharmaceuticals Inc.
- Type
- Human Prescription Drug
- Product code
- 0378-6322
Recalls naming this package
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
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.