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 (New 08/03/2018)

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 (New 08/03/2018)

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 during the next three to four months. Wholesalers and distributors are encouraged to continue to place their orders with Aurobindo Pharma USA as required. Aurobindo Pharma USA’s Valsartan products do not contain N-nitrosodimethylamine (“NDMA”), are not subject to a recall, remain as safe and effective treatment options, and are available on an allocation basis while manufacturing is being ramped up. 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 during the next three to four months. Wholesalers and distributors are encouraged to continue to place their orders with Aurobindo Pharma USA as required. Aurobindo Pharma USA’s Valsartan products do not contain N-nitrosodimethylamine (“NDMA”), are not subject to a recall, remain as safe and effective treatment options, and are available on an allocation basis while manufacturing is being ramped up. 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 during the next three to four months. Wholesalers and distributors are encouraged to continue to place their orders with Aurobindo Pharma USA as required. Aurobindo Pharma USA’s Valsartan products do not contain N-nitrosodimethylamine (“NDMA”), are not subject to a recall, remain as safe and effective treatment options, and are available on an allocation basis while manufacturing is being ramped up. 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 during the next three to four months. Wholesalers and distributors are encouraged to continue to place their orders with Aurobindo Pharma USA as required. Aurobindo Pharma USA’s Valsartan products do not contain N-nitrosodimethylamine (“NDMA”), are not subject to a recall, remain as safe and effective treatment options, and are available on an allocation basis while manufacturing is being ramped up. Demand increase for the drug

Camber Pharmaceuticals Inc. (Revised 08/23/2018)

Company Contact Information:
866-827-3647

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
40 mg (NDC 31722-745-30) Estimated shortage duration is from July 2018 to End of Sep. We will be able to supply with new product which is manufactured using new processed API from early Oct 2018 to all our current customers. Subject to nationwide voluntary recall

FDA Updates on Valsartan Recalls

Shortage of an active ingredient
80 mg (NDC 31722-746-90) Estimated shortage duration is from July 2018 to End of Sep. We will be able to supply with new product which is manufactured using new processed API from early Oct 2018 to all our current customers. Subject to nationwide voluntary recall

FDA Updates on Valsartan Recalls

Shortage of an active ingredient
160 mg (NDC 31722-746-90) Estimated shortage duration is from July 2018 to End of Sep. We will be able to supply with new product which is manufactured using new processed API from early Oct 2018 to all our current customers. Subject to nationwide voluntary recall

FDA Updates on Valsartan Recalls

Shortage of an active ingredient
320 mg (NDC 31722-748-90) Estimated shortage duration is from July 2018 to End of Sep. We will be able to supply with new product which is manufactured using new processed API from early Oct 2018 to all our current customers. Subject to nationwide voluntary recall

FDA Updates on Valsartan Recalls

Shortage of an active ingredient

Jubilant Cadista Pharmaceuticals, Inc. (New 08/03/2018)

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) Product is currently available at historically forecasted levels. Currently not accepting any NEW business. Other
80 mg (90's) (NDC 59746-0361-90) Product is currently available at historically forecasted levels. Other
160 mg (90's) (NDC 59746-0362-90) Product is currently available at historically forecasted levels. Other
320 mg (90's) (NDC 59746-0363-90) Product is currently available at historically forecasted levels. Other

Macleods Pharmaceuticals Limited (New 08/07/2018)

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 10/08/2018)

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 Mylan’s Valsartan Tablets are readily available and currently not in shortage Other
160 mg (90’s) (NDC 0378-5814-77) Available Mylan’s Valsartan Tablets are readily available and currently not in shortage Other
80 mg (90’s) (NDC 0378-5813-77) Available Mylan’s Valsartan Tablets are readily available and currently not in shortage Other
320 mg (90’s) (NDC 0378-5815-77) Available Mylan’s Valsartan Tablets are readily available and currently not in shortage Other

Novartis (Revised 09/10/2018)

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 (Revised 08/23/2018)

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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