FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Valsartan Tablets
Status: Currently in Shortage
»Date first posted: 08/03/2018
»Therapeutic Categories: Cardiovascular

FDA updates recalled valsartan-containing product information and reminds API manufacturers to evaluate processes for unsafe impurities
FDA Updates on Valsartan Recalls

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Alembic Pharmaceuticals (Reverified 07/10/2019)

Company Contact Information:
908-393-9604

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
40 mg bottle of 30 counts (NDC 62332-044-30) Available Other
40 mg bottle of 90 counts (NDC 62332-044-90) Available Other
40 mg bottle of 500 counts (NDC 62332-044-71) Available Other
80 mg bottle of 30 counts (NDC 62332-045-30) Available Other
80 mg bottle of 90 counts (NDC 62332-045-90) Available Other
80 mg bottle of 500 counts (NDC 62332-045-71) Available Other
160 mg bottle of 30 counts (NDC 62332-046-30) Available Other
160 mg bottle of 90 counts (NDC 62332-046-90) Available Other
160 mg bottle of 500 counts (NDC 62332-046-71) Available Other
320 mg bottle of 30 count (NDC 62332-047-30) Available Other
320 mg bottle of 90 count (NDC 62332-047-90) Available Other
320 mg bottle of 500 counts (NDC 62332-047-71) Available Other

Amneal Pharmaceutical (New 08/16/2018)

Company Contact Information:
866-525-7270

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
40 mg, 30 ct bottle (NDC 65162-837-03); 60 ct bottle (NDC 65162-837-06); 500 ct bottle (NDC 65162-837-50) Estimated release September 7, 2018 Other
80 mg, 90 ct bottle (NDC 65162-838-09); 500 ct bottle (NDC 65162-838-50); 1000 ct bottle (NDC 65162-838-11) Estimated release September 7, 2018 Other
160 mg, 90 ct bottle (NDC 65162-839-09); 500 ct bottle (NDC 65162-839-50); 1000 ct bottle (NDC 65162-839-11) Estimated release September 7, 2018 Other
320 mg, 90 ct bottle (NDC 65162-840-09); 500 ct bottle (NDC 65162-840-50); 1000 ct bottle (NDC 65162-840-11) Estimated release September 7, 2018 Other

Aurobindo Pharma (Revised 07/19/2019)

Company Contact Information:
732-839-9400

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Valsartan Tablets USP 40 mg. - 30/Bottle (NDC 65862-0570-30) Aurobindo Pharma USA’s Valsartan family of products are available under allocation. Regulatory Delays Demand increase for the drug
Valsartan Tablets USP 80 mg. - 90/Bottle (NDC 65862-0571-90) Aurobindo Pharma USA’s Valsartan family of products are available under allocation. Regulatory Delays Demand increase for the drug
Valsartan Tablets USP 160 mg. - 90/Bottle (NDC 65862-0572-90) Aurobindo Pharma USA’s Valsartan family of products are available under allocation. Regulatory Delays Demand increase for the drug
Valsartan Tablets USP 320 mg. - 90/Bottle (NDC 65862-0573-90 ) Aurobindo Pharma USA’s Valsartan family of products are available under allocation. Regulatory Delays Demand increase for the drug

Camber Pharmaceuticals Inc. (Revised 06/10/2019)

Company Contact Information:
866-827-3647

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
40 mg (NDC 31722-745-30) Currently not marketing this product Subject to nationwide voluntary recall

FDA Updates on Valsartan Recalls

Shortage of an active ingredient
80 mg (NDC 31722-746-90) Currently not marketing this product Subject to nationwide voluntary recall

FDA Updates on Valsartan Recalls

Shortage of an active ingredient
160 mg (NDC 31722-746-90) Currently not marketing this product Subject to nationwide voluntary recall

FDA Updates on Valsartan Recalls

Shortage of an active ingredient
320 mg (NDC 31722-748-90) Currently not marketing this product Subject to nationwide voluntary recall

FDA Updates on Valsartan Recalls

Shortage of an active ingredient

Jubilant Cadista Pharmaceuticals, Inc. (Revised 06/17/2019)

Company Contact Information:
800-313-4623

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
40 mg (30's) (NDC 59746-0360-30) Available Other
80 mg (90's) (NDC 59746-0361-90) Available Other
160 mg (90's) (NDC 59746-0362-90) Available Other
320 mg (90's) (NDC 59746-0363-90) Available Other

Macleods Pharmaceuticals Limited (Reverified 06/11/2019)

Company Contact Information:
888-677-0778

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Valsartan Tablets 40mg x 30's Bottle Pack (NDC 33342006207) Available Available
Valsartan Tablets 80mg x 90's Bottle Pack (NDC 33342006310) Available Available
Valsartan Tablets 160mg x 30's Bottle Pack (NDC 33342006410) Available Available
Valsartan Tablets 320mg x 30's Bottle Pack (NDC 33342006510) Available Available

Mylan Pharmaceuticals Inc. (Reverified 10/01/2019)

Company Contact Information:
800-796-9526

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
40 mg (30’s) (NDC 0378-5807-93) Available Other
160 mg (90’s) (NDC 0378-5814-77) Available Other
80 mg (90’s) (NDC 0378-5813-77) Available Other
320 mg (90’s) (NDC 0378-5815-77) Available Other

Novartis (Reverified 06/11/2019)

Company Contact Information:
888-669-6682

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
DIOVAN® scored tablets 40mg 30s 1 bottle of 30 tablets (NDC 0078-0423-15) Available Novartis’ Diovan Tablets are readily available and currently not in shortage Demand increase for the drug
DIOVAN® tablets 80mg 1 bottle of 90 tablets (NDC 0078-0358-34) Available Novartis’ Diovan Tablets are readily available and currently not in shortage Demand increase for the drug
DIOVAN® tablets 160mg 1 bottle of 90 tablets (NDC 0078-0359-34) Available Novartis’ Diovan Tablets are readily available and currently not in shortage Demand increase for the drug
DIOVAN® tablets 320mg 1 bottle of 90 count (NDC 0078-0360-34) Available Novartis’ Diovan Tablets are readily available and currently not in shortage Demand increase for the drug
Valsartan Tablets 40 mg 1 bottle of 90 tablets (NDC 0781-5607-31) Manufacture of the drug has been discontinued Discontinuation of the manufacture of the drug Discontinuation of the manufacture of the drug
Valsartan Tablets 80 mg 1 bottle of 90 tablets (NDC 0781-5608-92) Manufacture of the drug has been discontinued Discontinuation of the manufacture of the drug Discontinuation of the manufacture of the drug
Valsartan Tablets 160 mg 1 bottle of 90 tablets (NDC 0781-5618-92) Manufacture of the drug has been discontinued Discontinuation of the manufacture of the drug Discontinuation of the manufacture of the drug
Valsartan Tablets 320 mg 1 bottle of 90 tablets (NDC 0781-5619-92) Manufacture of the drug has been discontinued Discontinuation of the manufacture of the drug Discontinuation of the manufacture of the drug

Ohm Laboratories Inc. (New 08/03/2018)

Company Contact Information:
800-818-4555

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
40 mg (NDC 51660-140-30) Manufacturing resumes from September 2018 dependent on API supplies. Manufacturing stopped temporarily and currently not supplying. Discontinuation of the manufacture of the drug
80 mg (NDC 51660-141-90) Manufacturing resumes from September 2018 dependent on API supplies. Manufacturing stopped temporarily and currently not supplying. Discontinuation of the manufacture of the drug
160 mg (NDC 51660-142-90) Manufacturing resumes from September 2018 dependent on API supplies. Manufacturing stopped temporarily and currently not supplying. Discontinuation of the manufacture of the drug
320 mg (NDC 51660-143-90) Manufacturing resumes from September 2018 dependent on API supplies. Manufacturing stopped temporarily and currently not supplying. Discontinuation of the manufacture of the drug

Solco Healthcare US, LLC (Reverified 06/10/2019)

Company Contact Information:
866-931-9829

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
40mg 30’s (NDC 43547-0367-03) TBD Valsartan tablets are the subject of a nationwide voluntary recall for all lots, which was announced on July 13, 2018.

FDA Updates on Valsartan Recalls

Other
160mg 90’s (NDC 43547-0369-09) TBD Valsartan tablets are the subject of a nationwide voluntary recall for all lots, which was announced on July 13, 2018.

FDA Updates on Valsartan Recalls

Other
80mg 90’s (NDC 43547-0368-09) TBD Valsartan tablets are the subject of a nationwide voluntary recall for all lots, which was announced on July 13, 2018.

FDA Updates on Valsartan Recalls

Other
320mg 90’s (NDC 43547-0370-09) TBD Valsartan tablets are the subject of a nationwide voluntary recall for all lots, which was announced on July 13, 2018.

FDA Updates on Valsartan Recalls

Other

Torrent Pharma Inc. (Revised 08/23/2018)

Company Contact Information:
908-280-3333

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
40 mg (NDC 13668-067-30) Unavailable Subject to nationwide voluntary recall

FDA Updates on Valsartan Recalls

Discontinuation of the manufacture of the drug
80 mg (NDC 13668-068-90) Unavailable Subject to nationwide voluntary recall

FDA Updates on Valsartan Recalls

Discontinuation of the manufacture of the drug
160 mg (NDC 13668-069-90) Unavailable Subject to nationwide voluntary recall

FDA Updates on Valsartan Recalls

Discontinuation of the manufacture of the drug
320 mg (NDC 13668-070-90) Unavailable Subject to nationwide voluntary recall

FDA Updates on Valsartan Recalls

Discontinuation of the manufacture of the drug

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