August 29, 2018
Jubilant Cadista Pharmaceuticals Inc. is pulling more than 45,000 bottles of valsartan tablets because an incorrect grade of excipient may have been used during manufacturing. The recall was included in the August 29, 2018, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects the following products, which were distributed throughout the United States:
- valsartan tablets USP, 40 mg, 30-count bottles (NDC 59746-360-30), from lots VR117014A and VR117015A (Exp. 8/19);
- valsartan tablets USP, 80 mg, 90-count bottles (NDC 59746-361-90), from lot VR217013A (Exp. 8/19);
- valsartan tablets USP, 160 mg, 90-count bottles (NDC 59746-362-90), from lots VR317040A, VR317041A, VR317042A, and VR317043A (Exp. 8/19); and
- valsartan tablets USP, 320 mg, 90-count bottles (NDC 59746-363-90); from lots VR417062A (Exp. 9/19), and VR417063A and VR417064A (Exp. 10/19).
Jubilant Cadista Pharmaceuticals voluntarily initiated the recall August 14, 2018. On August 17, 2018, the FDA designated the recall Class III, suggesting use of the product is unlikely to cause adverse health consequences.
Valsartan is a prescription angiotensin receptor blocker used for the treatment of high blood pressure and congestive heart failure.
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