Valsartan Tablets USP, 160 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 59746-362-90
Reported: August 29, 2018 Initiated: August 14, 2018 #D-1105-2018
Product Description
Valsartan Tablets USP, 160 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 59746-362-90
Reason for Recall
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Details
- Recalling Firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Units Affected
- 18,947 bottles
- Distribution
- Product was distributed throughout the United States to wholesalers and retailers.
- Location
- Salisbury, MD
Frequently Asked Questions
What product was recalled? ▼
Valsartan Tablets USP, 160 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 59746-362-90. Recalled by Jubilant Cadista Pharmaceuticals, Inc.. Units affected: 18,947 bottles.
Why was this product recalled? ▼
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 29, 2018. Severity: Low. Recall number: D-1105-2018.
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