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Recall 2018-205B: Mylan - Valsartan - NYC - Consumer


URGENT!!!     ADDITIONAL NDCS UPDATED!!!     URGENT!!!

Description Lot # NDC UPC
AMLOD/VALSAR TB 10/160MG MYL30 ALL LOTS 00378172293 30378172293
AMLOD/VALSAR TB 10/320MG MYL30 ALL LOTS 00378172493 30378172493
AMLOD/VALSART TB 5/160MG MYL30 ALL LOTS 00378172193 30378172193
AMLOD/VALSART TB 5/320MG 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 TB 160MG/12.5MGMYL90 ALL LOTS 00378632277 30378632277
VALS+HYDR TB 320/12.5MGMYLN500 ALL LOTS 00378632405 30378632405
VALS+HYDR TB 320MG/25MGMYLN500 ALL LOTS 00378632505 30378632505
VALS+HYDR TB 80MG/12.5MGMYLN90 ALL LOTS 00378632177 30378632177
VALS+HYDR TB 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
VALS+HYDR 160/25MG *SD* MYL500 ALL LOTS 00378632305 30378632305
VALS+HYDR 320/12.5MG *SD*MYL90 ALL LOTS 00378632477 30378632477
VALS+HYDR TB 320/25MG*SD*MYL90 ALL LOTS 00378632577 30378632577
VALS+HYD TB 160/12.5MG*SD*MYL90 ALL LOTS 00378632277 30378632277
VALS+HYDR TB 80/12.5MG*SD*MYL90 ALL LOTS 00378632177 30378632177


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.


Contact:

Stericycle: Stericycle Solco Healthcare 888-871-7116