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Mylan Valsartan Tablets

Recall Title: Class 1 Mylan Valsartan Tablets

Date: Nov-26-2018

UPC Code Name & Product Description Identifying Marks (lot #s, Dates, etc.)

30378172293 AMLOD/VALSAR TB10/160MG MYL30 Lot# 3079500; Exp Date: 01/31/20; NDC: 00378172293; Econo # 3437167
30378172493 AMLOD/VALSAR TB10/320MG MYL30 Lot# 3079709, 3079708, 3077618, 3061986; Exp Date: 01/31/20, 01/31/20, 11/30/19, 11/30/18; NDC: 00378172493; Econo #3437183
30378172193 AMLOD/VALSART TB5/160MG MYL30 Lot# 3066051; Exp Date: 3/31/19; NDC: 00378172193; Econo #3437142
30378632505 VALS+HYDR TB320MG/25MGMYLN500 Lot#3093804, 3084886; Exp Date:12/31/19, 2/28/19; NDC: 00378632505; Econo #1379072
30378581477 VALSARTAN TAB 160 MG MYL 90 Lot#3071352; Exp Date: 7/31/19; NDC: 00378581477 ; Econo #3412673
30378581577 VALSARTAN TAB 320 MG MYL 90 Lot# 3081499, 3080010, 3080009, 3079205; Exp Date: 3/31/20, 2/28/20, 2/28/20, 1/31/20; NDC: 00378581577; Econo # 3412699
30378580793 VALSARTAN TAB 40 MG MYL 30 Lot# 3061169; Exp Date: 11/30/18; NDC: 00378580793; Econo # 3412640
30378581377 VALSARTAN TAB 80 MG MYL 90 Lot# 3063782; Exp Date: 1/31/19; NDC: 00378581377; Econo # 3412665

Reason for Recall:
Mylan Pharmaceuticals is voluntarily recalling the above item(s)/lot(s) due to detected trace amounts of an impurity N-nitrosodieethylamine (NDEA).

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