Class II · Moderate risk Ongoing
Diovan
Reason Failed Dissolution Specifications
Valsartan Tablets USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
What was recalled
Valsartan Tablets USP, 320 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-363-90
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
- NDC code
- 59746-363-90
- Origin
- MD, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1106-2018
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Valsartan recalls
See all
Class II · Moderate risk Terminated
Valsartan Tablets USP 40 mg 30 Scored Tablets Rx Only NDC…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Ongoing
Valsartan Tablets 320 mg USP
Reason CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Class II · Moderate risk Ongoing
Valsartan Tablets 160 mg USP
Reason CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Class II · Moderate risk Ongoing
Valsartan Tablets 80 mg USP
Reason CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
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