Drug recall
Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg*/40 mg, 30 count bottles, Rx Only, Manufactured for…
FDA recall event 68793 · Class II · Daiichi Sankyo Pharma Development
Key facts
| Event ID | 68793 |
|---|---|
| Recall numbers | D-1501-2014, D-1502-2014, D-1503-2014, D-1504-2014, D-1505-2014, D-1506-2014, D-1507-2014, D-1508-2014 |
| Recalling firm | Daiichi Sankyo Pharma Development |
| Product type | Drugs |
| Products | Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg*/40 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc. Parsippany, NJ 07054 NDC 65597-113-30, Benicar HCT Tablets (olmesartan medoxomil, hydrochlorothiazide) 20 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-105-30, Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-106-30, Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/25 mg, 30 and 90 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-107-30 and NDC…, Benicar Tablets (olmesartan medoxomil) 20 mg, 30 and 90 count, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-103-30 and NDC 65597-103-90 and 3 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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. |
| Initiation date | Jul 12, 2014 |
| Report date | Aug 6, 2014 |
| Termination date | Mar 16, 2015 |
| City | Edison |
| State | NJ |
| Country | United States |
| FEI number | 3003089536 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: