Class II · Moderate risk Ongoing
Bisoprolol Fumarate and Hydrochlorothiazide tablets
Reason cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Benicar HCT Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
What was recalled
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
- Recalling firm
- Daiichi Sankyo Pharma Development
- NDC code
- 65597-106-30
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1507-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Hydrochlorothiazide recalls
See all
Class III · Low risk Ongoing
Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Reason Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Class II · Moderate risk Ongoing
Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg
Reason Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
Class II · Moderate risk Ongoing
Losartan Potassium and Hydrochlorothiazide Tablets
Reason Presence of foreign substance: plastic-like substance.
Class III · Low risk Terminated
Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Reason Failed Impurities/Degradation Specifications
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