NDC 71205-063
Irbesartan and Hydrochlorothiazide 150 mg / 12.5 mg tablet
On the label: Proficient Rx LP. It's repackaged: Proficient Rx LP rebottles it from Solco Healthcare U.S., LLC's NDC 43547-330.
Where the pills inside were made
This label doesn't name the factory that makes the drug. Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants Solco Healthcare U.S., LLC names for other drugs.
Repackaging site
- Proficient Rx LP, Thousand Oaks, CA, United States · relabels it
Recalls
- Jan 18, 2019 · Class II · Prinston Pharmaceutical Inc
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Lots: 325B18004 - Jan 18, 2019 · Class II · Prinston Pharmaceutical Inc
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Lots: 327A18001 327A18002 - Jan 18, 2019 · Class II · Prinston Pharmaceutical Inc
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Lots: 327B18008 327B18009 - Jan 18, 2019 · Class II · Prinston Pharmaceutical Inc
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Lots: 325D18004 325D18005 - May 30, 2016 · Class III · Prinston Pharmaceutical Inc
Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container.
Lots: Lot #: 327B16002, Exp 12/17
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Hydrochlorothiazide and Irbesartan: every company that makes it
- Form
- tablet, oral
- Strength
- 150 mg / 12.5 mg
- Approval
- ANDA ANDA203072
- On the market since
- Mar 1, 2014
- Package NDCs
71205-063-3071205-063-6071205-063-90- Official label
- DailyMed (National Library of Medicine), updated Oct 1, 2024
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