FDA (Drugs) recall action 68793
The FDA (Drugs) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Daiichi Sankyo is recalling specific lots of Benicar HCT tablets because they were not stored at controlled room temperature during shipping.
Daiichi Sankyo is recalling 68 bottles of Welchol Tablets (colesevelam HCl) 625 mg because they were not stored at controlled room temperature during shipping.
Daiichi Sankyo is recalling 262 bottles of Benicar Tablets because they were not stored at controlled room temperature during shipping.
Daiichi Sankyo is recalling 108 bottles of Benicar HCT 20 mg/12.5 mg tablets because they were not stored at controlled room temperature during shipping.
Daiichi Sankyo is recalling Benicar Tablets (olmesartan medoxomil) 40 mg because some products were not stored at controlled room temperature during shipping.
Daiichi Sankyo is recalling specific lots of Tribenzor tablets because they were not stored at controlled room temperature during shipping.
Daiichi Sankyo is recalling 5 bottles of Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg/40 mg because they were not stored at controlled room temperature during shipping.
Daiichi Sankyo is recalling 86 bottles of Benicar HCT 40 mg/12.5 mg because they were not stored at controlled room temperature during shipping.