Class II · Moderate risk
Valsartan 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 0378-5815-77 recalled?
Valsartan · 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5815-77)
Yes — this exact package was recalled
2 FDA recalls name the code 0378-5815-77 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.
2 of these recalls are still ongoing.
- Active ingredient
- valsartan
- Strength
- VALSARTAN 320 mg/1
- Form
- Tablet, Film Coated · Oral
- Labeler
- Mylan Pharmaceuticals Inc.
- Type
- Human Prescription Drug
- Product code
- 0378-5815
Recalls naming this package
Class II · Moderate risk
Valsartan Tablets
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
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
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