Recall 2018-205A: Mylan - Valsartan - NYC - Consumer
URGENT!!! ADDITIONAL NDCS UPDATED!!! URGENT!!!
|Description ||Lot # ||NDC || UPC|
|AMLOD/VALSAR TB10/160MG MYL30@ ||ALL LOTS ||00378172293 ||30378172293|
|AMLOD/VALSAR TB10/320MG MYL30@ ||ALL LOTS ||00378172493 ||30378172493|
|AMLOD/VALSART TB5/160MG MYL30@ ||ALL LOTS ||00378172193 ||30378172193|
|AMLOD/VALSART TB5/320MG MYL30@ ||ALL LOTS ||00378172393 ||30378172393|
|VALS+HYDR TB 160/25MG MYLN500@ ||ALL LOTS ||00378632305 ||30378632305|
|VALS+HYDR TB 160MG/25MGMYLN90@ ||ALL LOTS ||00378632377 ||30378632377|
|VALS+HYDR TB 320/12.5MGMYLN90@ ||ALL LOTS ||00378632477 ||30378632477|
|VALS+HYDR TB 320MG/25MGMYLN90@ ||ALL LOTS ||00378632577 ||30378632577|
|VALS+HYDR TB 80/12.5MGMYLN500@ ||ALL LOTS ||00378632105 ||30378632105|
|VALS+HYDR TB160MG/12.5MGMYL90@ ||ALL LOTS ||00378632277 ||30378632277|
|VALS+HYDR TB320/12.5MGMYLN500@ ||ALL LOTS ||00378632405 ||30378632405|
|VALS+HYDR TB320MG/25MGMYLN500@ ||ALL LOTS ||00378632505 ||30378632505|
|VALS+HYDR TB80MG/12.5MGMYLN90@ ||ALL LOTS ||00378632177 ||30378632177|
|VALS+HYDRTB 160/12.5MGMYLN500@ ||ALL LOTS ||00378632205 ||30378632205|
|VALSARTAN TAB 160 MG MYL 90@ ||ALL LOTS ||00378581477 ||30378581477|
|VALSARTAN TAB 320 MG MYL 90@ ||ALL LOTS ||00378581577 ||30378581577|
|VALSARTAN TAB 40 MG MYL 30@ ||ALL LOTS ||00378580793 ||30378580793|
|VALSARTAN TAB 80 MG MYL 90@ ||ALL LOTS ||00378581377 ||30378581377|
Mylan Pharmaceuticals is voluntarily recalling the above item(s)/lot(s) due to detected trace amounts of an impurity N-nitrosodieethylamine (NDEA). This recall is to the Consumer level. Affected product started shipping March 2017.
Consumers should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on valsartan should continue taking their medication, as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment.
For questions about this recall, please contact Stericycle at 888-406-9305.
This recall is being conducted with the knowledge of the FDA.
Stericycle: Stericycle Solco Healthcare 888-871-7116