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Expansion of recall of valsartan drugs to include additional lots, as a precaution

Issued August 18, 2018
Issue
Hazard description
Product safety
What to do
Patients taking affected valsartan medications should: Continue taking their valsartan medication unless they have been advised to stop by their health care provider. Contact their health care provider as soon as possible to discuss treatment options if they have been using an affected product. Pharmacists may be able to provide a product not affected by the recall, or doctors may prescribe a different medication for their patients’ conditions. Ask their pharmacist if they are unsure whether they are using a recalled product. List of recalled valsartan products: Product name/Active Pharmaceutical Ingredient DIN Strength Lot # Active Pharmaceutical Ingredient Manufacturer Date added MYLAN-VALSARTAN 02383527 40 mg All lots Mylan Laboratories Limited November 28, 2018 ( Notice ) MYLAN-VALSARTAN 02383535 80 mg All lots Mylan Laboratories Limited November 28, 2018 ( Notice ) MYLAN-VALSARTAN 02383543 160 mg All lots Mylan Laboratories Limited November 28, 2018 ( Notice ) MYLAN-VALSARTAN 02383551 320 mg All lots Mylan Laboratories Limited November 28, 2018 ( Notice ) TEVA-VALSARTAN/HCTZ TABLETS 02356996 80/12.5 mg 35211136A Zhejiang Huahai Pharmaceuticals August 17, 2018 TEVA-VALSARTAN/HCTZ TABLETS 02357003 160/12.5 mg 35211335A Zhejiang Huahai Pharmaceuticals August 17, 2018 TEVA-VALSARTAN/HCTZ TABLETS 02357003 160/12.5 mg 35211844R Zhejiang Huahai Pharmaceuticals August 17, 2018 TEVA-VALSARTAN/HCTZ TABLETS 02357011 160/25 mg 35210937R Zhejiang Huahai Pharmaceuticals August 17, 2018 TEVA-VALSARTAN/HCTZ TABLETS 02357011 160/25 mg 35210938R Zhejiang Huahai Pharmaceuticals August 17, 2018 TEVA-VALSARTAN/HCTZ TABLETS 02357011 160/25 mg 35210939R Zhejiang Huahai Pharmaceuticals August 17, 2018 TEVA-VALSARTAN/HCTZ TABLETS 02357011 160/25 mg 35210940R Zhejiang Huahai Pharmaceuticals August 17, 2018 TEVA-VALSARTAN/HCTZ TABLETS 02357038 320/12.5 mg 35211546R Zhejiang Huahai Pharmaceuticals August 17, 2018 TEVA-VALSARTAN/HCTZ TABLETS PP 30s 02357046 320/25 mg 35212731R Zhejiang Huahai Pharmaceuticals July 9, 2018 ACT-VALSARTAN 40MG FC TABLETS 100 02337487 40 mg K47338 Zhejiang Huahai Pharmaceuticals July 9, 2018 ACT-VALSARTAN 80MG FC TABLETS 100 02337495 80 mg K45370 Zhejiang Huahai Pharmaceuticals July 9, 2018 ACT-VALSARTAN 80MG FC TABLETS 100 02337495 80 mg K47652 Zhejiang Huahai Pharmaceuticals July 9, 2018 ACT-VALSARTAN 80MG FC TABLETS 100 02337495 80 mg K47653 Zhejiang Huahai Pharmaceuticals July 9, 2018 ACT-VALSARTAN 80MG FC TABLETS 100 02337495 80mg K47654 Zhejiang Huahai Pharmaceuticals July 9, 2018 ACT-VALSARTAN 160MG FC TABLETS 100 02337509 160 mg K39691 Zhejiang Huahai Pharmaceuticals July 9, 2018 ACT-VALSARTAN 160MG FC TABLETS 100 02337509 160 mg K44167 Zhejiang Huahai Pharmaceuticals July 9, 2018 ACT-VALSARTAN 160MG FC TABLETS 100 02337509 160 mg K47657 Zhejiang Huahai Pharmaceuticals July 9, 2018 ACT-VALSARTAN 160MG FC TABLETS 100 02337509 160 mg K47658 Zhejiang Huahai Pharmaceuticals July 9, 2018 ACT-VALSARTAN 320MG FC TABLETS 100 02337517 320 mg K44166 Zhejiang Huahai Pharmaceuticals July 9, 2018 ACT-VALSARTAN 320MG FC TABLETS 100 02337517 320 mg K45371 Zhejiang Huahai Pharmaceuticals July 9, 2018 SANDOZ VALSARTAN 40 MG 02356740 40 mg All lots Zhejiang Huahai Pharmaceuticals July 9, 2018 SANDOZ VALSARTAN 80 MG 02356759 80 mg All lots Zhejiang Huahai Pharmaceuticals July 9, 2018 SANDOZ VALSARTAN 160 MG 02356767 160 mg All lots Zhejiang Huahai Pharmaceuticals July 9, 2018 SANDOZ VALSARTAN 320 MG 02356775 320 mg All lots Zhejiang Huahai Pharmaceuticals July 9, 2018 SANIS VALSARTAN 40 MG 02366940 40 mg All lots Zhejiang Huahai Pharmaceuticals July 9, 2018 SANIS VALSARTAN 80 MG 02366959 80 mg All lots Zhejiang Huahai Pharmaceuticals July 9, 2018 SANIS VALSARTAN 160 MG 02366967 160 mg All lots Zhejiang Huahai Pharmaceuticals July 9, 2018 SANIS VALSARTAN 320 MG 02366975 320 mg All lots Zhejiang Huahai Pharmaceuticals July 9, 2018 PRO DOC LIMITEE VALSARTAN 40 MG 02367726 40 mg All lots Zhejiang Huahai Pharmaceuticals July 9, 2018 PRO DOC LIMITEE VALSARTAN 80 MG 02367734 80 mg All lots Zhejiang Huahai Pharmaceuticals July 9, 2018 PRO DOC LIMITEE VALSARTAN 160 MG 02367742 160 mg All lots Zhejiang Huahai Pharmaceuticals July 9, 2018 PRO DOC LIMITEE VALSARTAN 320 MG 02367750 320 mg All lots Zhejiang Huahai Pharmaceuticals July 9, 2018 SIVEM PHARMACEUTICAL ULC VALSARTAN 40 MG 02384523 40 mg All lots Zhejiang Huahai Pharmaceuticals July 9, 2018 SIVEM PHARMACEUTICAL ULC VALSARTAN 80 MG 02384531 80 mg All lots Zhejiang Huahai Pharmaceuticals July 9, 2018 SIVEM PHARMACEUTICAL ULC VALSARTAN 160 MG 02384558 160 mg All lots Zhejiang Huahai Pharmaceuticals July 9, 2018 SIVEM PHARMACEUTICAL ULC VALSARTAN 320 MG 02384566 320 mg All lots Zhejiang Huahai Pharmaceuticals July 9, 2018 List of valsartan products that are NOT recalled: Product name/Active Pharmaceutical Ingredient DIN Strength Lot # APO-VALSARTAN/HCTZ 02382555 160/12.5 mg All lots APO-VALSARTAN/HCTZ 02382563 160/25 mg All lots AURO-VALSARTAN 02414201 40 mg All lots AURO-VALSARTAN 02414228 80 mg All lots AURO-VALSARTAN 02414236 160 mg All lots AURO-VALSARTAN 02414244 320 mg All lots AURO-VALSARTAN HCT 02408112 80/12.5 mg All lots AURO-VALSARTAN HCT 02408120 160/12.5 mg All lots AURO-VALSARTAN HCT 02408139 160/25 mg All lots AURO-VALSARTAN HCT 02408147 320/12.5 mg All lots AURO-VALSARTAN HCT 02408155 320/25 mg All lots PMS-VALSARTAN 02312999 40 mg All lots PMS-VALSARTAN 02313006 80 mg All lots PMS-VALSARTAN 02313014 160 mg All lots PMS-VALSARTAN 02344564 320 mg All lots RAN-VALSARTAN 02363062 40 mg All lots RAN-VALSARTAN 02363100 80 mg All lots RAN-VALSARTAN 02363119 160 mg All lots DIOVAN 02270528 40 mg All lots DIOVAN 02289504 320 mg All lots DIOVAN VALSARTAN 02236809 160 mg All lots DIOVAN VALSARTAN 02244782 160 mg All lots DIOVAN VALSARTAN 02236808 80 mg All lots DIOVAN VALSARTAN 02244781 80 mg All lots DIOVAN VALSARTAN HCT 02241900 80/12.5 mg All lots DIOVAN VALSARTAN HCT 02241901 160/12.5 mg All lots DIOVAN VALSARTAN HCT 02246955 160/25 mg All lots DIOVAN VALSARTAN HCT 02308908 320 mg/12.5 mg All lots DIOVAN HCT 02308916 320 mg/25mg All lots SANDOZ VALSARTAN HCT 02356694 80/12.5 mg All lots SANDOZ VALSARTAN HCT 02356708 160/12.5 mg All lots SANDOZ VALSARTAN HCT 02356716 160/25 mg All lots SANDOZ VALSARTAN HCT 02356724 320/12.5 mg All lots SANDOZ VALSARTAN HCT 02356732 320/25 mg All lots SANIS VALSARTAN HCT 02367009 80/12.5 mg All lots SANIS VALSARTAN HCT 02367017 160/12.5 mg All lots SANIS VALSARTAN HCT 02367025 160/25 mg All lots SANIS VALSARTAN HCT 02367033 320/12.5 mg All lots SANIS VALSARTAN HCT 02367041 320/25 mg All lots SIVEM PHARMACEUTICALS ULC VALSARTAN HCT 02384736 80/12.5 mg All lots SIVEM PHARMACEUTICALS ULC VALSARTAN HCT 02384744 160/12.5 mg All lots SIVEM PHARMACEUTICALS ULC VALSARTAN HCT 02384752 160/25 mg All lots SIVEM PHARMACEUTICALS ULC VALSARTAN HCT 02384760 320/12.5 mg All lots SIVEM PHARMACEUTICALS ULC VALSARTAN HCT 02384779 320/25 mg All lots TEVA-VALSARTAN 02356643 40 mg All lots TEVA-VALSARTAN 02356651 80 mg All lots TEVA-VALSARTAN 02356678 160 mg All lots TEVA-VALSARTAN 02356686 320 mg All lots TEVA-VALSARTAN/HCTZ 02356996 80/12.5 mg All lots except for the recalled lot 35211136A TEVA-VALSARTAN/HCTZ 02357003 160/12.5 mg All lots except for the recalled lots 35211335A and 35211844R- TEVA-VALSARTAN/HCTZ 02357011 160/25 mg All lots except for the recalled lots 35210937R 35210938R 35210939R 35210940R TEVA-VALSARTAN/HCTZ 02357038 320/12.5 mg All lots except for the recalled lot 35211546R TEVA-VALSARTAN/HCTZ 02357046 320/25 mg All lots except for the recalled lot 35212731R PRO DOC VALSARTAN /HCTZ 02367769 80/12.5 mg All lots PRO DOC VALSARTAN /HCTZ 02367777 160/12.5 mg All lots PRO DOC VALSARTAN /HCTZ 02367785 160/25 mg All lots ENTRESTO 02446928 26 mg All lots ENTRESTO 02446936 51 mg All lots ENTRESTO 02446944 103 mg All lots