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Four Firms Issue New Recalls for Losartan


May 09, 2019

Four firms have issued new recalls for losartan products after higher-than-acceptable levels of an N-Methylnitrosobutyric acid (NMBA) impurity were detected in the drugs. The recalls are included in the May 8, 2019, US Food and Drug Administration (FDA) Enforcement Report.

Legacy Pharmaceutical Packaging is recalling losartan potassium tablets, 50 mg, 30-tablet bottles (NDC 68645-494-54) from lot 181598 (Exp. 2/21). The bottles were manufactured for Torrent Pharma Inc., packaged by Legacy Pharmaceutical Packaging, and distributed by the Kroger Co. in Tennessee and Arizona.

AvKare Inc. is recalling the following, which were distributed throughout the United States:

  • losartan potassium tablets, 25 mg, 50 tablets (5 x 10) unit dose (NDC 50268-516-15), from lot 19554 (Exp. 4/30/19); and
  • losartan potassium tablets, 50 mg, 50 tablets (5 x 10) unit dose (NDC 50268-517-15), from lot 20121 (Exp. 6/30/19).

Torrent Pharma Inc. is recalling the following, which were distributed throughout the United States and in Puerto Rico:

  • losartan potassium tablets, 25 mg, 90-count bottles (NDC 13668-113-90) from lot BDK1C003 (Exp. 7/31/19);
  • losartan potassium tablets, 25 mg, 1000-count bottles (NDC 13668-113-10) from lots BDK1C002 (Exp. 7/31/19), and 4DU1D004, 4DU1D005, and 4DU1D006 (Exp. 12/31/19);
  • losartan potassium tablets, 50 mg, 90-count bottles (NDC 13668-409-90) from lots 4DU2D005 and 4DU2D006 (Exp. 12/31/19), 4DU2D026, 4DU2D027, and 4DU2D029 (Exp. 3/31/20), and 4DU2E007 (Exp. 12/31/20);
  • losartan potassium tablets, 50 mg, 1000-count bottles (NDC 13668-409-10) from lots 4DU2D017 (Exp. 2/29/20), 4DU2D025 and 4DU2D028 (Exp. 3/31/20), 4DU2D040, 4DU2D041, 4DU2D042, 4DU2D045, 4DU2D046, 4DU2D047, and 4DU2D048 (Exp. 8/31/20), BDK2E001 (Exp. 12/31/20), 4DU2E042 and 4DU2E044 (Exp. 2/28/21), and BDK2E012 and BDK2E013 (Exp. 8/31/21);
  • losartan potassium tablets, 100 mg, 90-count bottles (NDC 13668-115-90) from lot 4DU3E016 (Exp. 1/31/21);
  • losartan potassium tablets, 100 mg, 1000-count bottles (NDC 13668-115-10) from lots 4DU3C012 (Exp. 7/31/19), 4DU3C015, 4DU3C016, and 4DU3C017 (Exp. 8/31/19), 4DU3C031 (Exp. 9/30/19), 4DU3D007 and 4DU3D008 (Exp. 1/31/20), 4DU3E017 (Exp. 1/31/21), and 4DU3E019 (Exp. 2/28/21);
  • losartan potassium and hydrochlorothiazide tablets, 50 mg/12.5 mg, 30-count bottles (NDC 13668-116-30) from lots BP02C051 (Exp. 10/31/19), BP02D005 (Exp. 12/31/19), and BEF7D047 (Exp. 11/30/20);
  • losartan potassium and hydrochlorothiazide tablets, 50 mg/12.5 mg, 90-count bottles (NDC 13668-116-90) from lots BP02C050 (Exp. 10/31/19), BP02D006 and BP02D007 (Exp. 12/31/19), BP02D012 (Exp. 1/31/20), BEF7D003 (Exp. 3/31/20), BEF7D026, BEF7D027, and BEF7D028 (Exp. 8/31/20), BEF7D045 and BEF7D046 (Exp. 11/30/20), and BEF7E005 (Exp. 1/31/21);
  • losartan potassium and hydrochlorothiazide tablets, 50 mg/12.5 mg, 1000-count bottles (NDC 13668-116-10) from lots BP02C051 and BP02C052 (Exp. 10/31/19), BEF7D005 (Exp. 3/31/20), BEF7D029 and BEF7D030 (Exp. 8/31/20), BEF7D048 (Exp. 11/30/20), and BEF7E001, BEF7E002, BEF7E003, and BEF7E004 (Exp. 12/31/20);
  • losartan potassium and hydrochlorothiazide tablets, 100 mg/12.5 mg, 90-count bottles (NDC 13668-117-90) from lots BX35D024 (Exp. 1/31/20), and BEF8D060, BEF8D061, BEF8D062, BEF8D063, and BEF8D064 (Exp. 11/30/20);
  • losartan potassium and hydrochlorothiazide tablets, 100 mg/12.5 mg, 1000-count bottles (NDC 13668-117-10) from lots BEF8D059 (Exp. 11/30/20), and BEF8E004 and BEF8E005 (Exp. 1/31/21);
  • losartan potassium and hydrochlorothiazide tablets, 100 mg/25 mg, 30-count bottles (NDC 13668-118-30) from lot BEF6D054 (Exp. 8/31/20); and
  • losartan potassium and hydrochlorothiazide tablets, 100 mg/25 mg, 90-count bottles (NDC 13668-118-90) and 1000-count bottles (NDC 13668-118-10) from lots BP04C092, (Exp. 10/31/19), BP04D012 and BP04D013 (Exp. 12/31/19), BEF6D012 and BEF6D013 (Exp. 3/31/20), BEF6D060, BEF6D061, and BEF6D063 (Exp. 9/30/20), BEF6D076, BEF6D077, BEF6D078, and BEF6D079 (Exp. 10/31/20), BEF6D100, BEF6D101, and BEF6D102 (Exp. 11/30/20), and BEF6E001, BEF6E002, BEF6E003, BEF6E004, BEF6E008, BEF6E009, BEF6E010, BEF6E011, and BEF6E012 (Exp. 12/31/20). 

RemedyRepack Inc. is recalling losartan potassium and hydrochlorothiazide tablets, 100 mg/12.5 mg, 90-count bottles (NDC 70518-1560-00) from lot B0517068-101618 (Exp. 10/19). The bottles were manufactured by Torrent Pharmaceuticals and distributed by RemedyRepack in Florida.

The FDA has designated the voluntary recalls Class II, communicating use of the affected drugs may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm. 

Losartan is a prescription angiotensin receptor blocker used to treat high blood pressure and to protect kidneys from diabetes-related damage.

Jolynn Tumolo

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