Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bottle (NDC 0378-6324-77), (b) 500-count bottles (NDC 0378-6324-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
Drug Recall
Official source record
- Recall number
- D-0331-2019
- Event ID
- 81707
- Classification
- Class II
- Status
- Ongoing
- Recalling company
- Mylan Laboratories Limited, (Nashik FDF)
- Reason for recall
- GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
- Report date
- December 19, 2018
- Recall initiation date
- December 4, 2018
- Termination date
- Not terminated as of this source record
- Distribution pattern
- Product was distributed throughout the United States to several major distributors, including Puerto Rico.
Drug product identifiers
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Brand name
- VALSARTAN AND HYDROCHLOROTHIAZIDE
- Generic name
- VALSARTAN AND HYDROCHLOROTHIAZIDE
- Substance names
- HYDROCHLOROTHIAZIDE; VALSARTAN
- Product NDCs
- 0378-6321; 0378-6322; 0378-6323; 0378-6324; 0378-6325
- Package NDCs
- 0378-6321-05; 0378-6321-77; 0378-6322-05; 0378-6322-77; 0378-6323-05; 0378-6323-77; 0378-6324-05; 0378-6324-77; 0378-6325-05; 0378-6325-77
- Route
- ORAL
Where this information comes from
View FDA enforcement record -- the specific openFDA drug enforcement record this summary was built from.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for details.
Retrieved by Public Health Trace:
Frequently asked questions
What does a Class II mean?
A situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote.
Is this recall still active?
According to the FDA, this recall's status is "Ongoing." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this medication?
Do not start, stop, or change any medication based on this page. Follow the instructions published by the FDA and the recalling company (see the source links below), and talk to your pharmacist or physician if you have questions about a specific medication.
Where can I find more official information?
The source links below, published by the FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.
Public Health Trace republishes official FDA drug recall information -- it is not affiliated with the FDA, does not verify or supplement what the source has published, and does not provide medical advice. Never start, stop, or change a medication based on this page. Always follow the guidance of your pharmacist or physician, and consult the official source links above for the most current information. Read the full medical disclaimer.
