Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-363-90
Reported: June 13, 2018 Initiated: May 25, 2018 #D-0876-2018
Product Description
Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-363-90
Reason for Recall
Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
Details
- Recalling Firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Units Affected
- 2,328 bottles (Lot VR417065A) and 2,352 bottles (Lot VR417066A)
- Distribution
- IN, MI, MS, NC, NJ, NY and OH
- Location
- Salisbury, MD
Frequently Asked Questions
What product was recalled? ▼
Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-363-90. Recalled by Jubilant Cadista Pharmaceuticals, Inc.. Units affected: 2,328 bottles (Lot VR417065A) and 2,352 bottles (Lot VR417066A).
Why was this product recalled? ▼
Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 13, 2018. Severity: Low. Recall number: D-0876-2018.
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