NDC 70518-1550

Irbesartan and Hydrochlorothiazide 300 mg / 12.5 mg tablet

On the label: Remedyrepack Inc.. It's repackaged: Remedyrepack Inc. rebottles it from Solco Healthcare U.S., LLC's NDC 43547-331.

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.

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: 300 mg / 12.5 mg
Approval: ANDA ANDA203072
On the market since: Oct 18, 2018
Package NDCs: 70518-1550-0 70518-1550-1
Official label: DailyMed (National Library of Medicine), updated Jul 7, 2026

Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?