Losartan and Hydrochlorothiazide oral tablet, Torrent, 50 mg/ 12.5 mg, bottle, 1000 count, NDC 13668-0116-10 - discontinued Reason for the Shortage Beginning in mid-2018, FDA found that several angiotensin II
Angiotensin
Angiotensin is a peptide hormone that causes vasoconstriction and a subsequent increase in blood pressure. It is part of the renin-angiotensin system, which is a major target for drugs that lower blood pressure. Angiotensin also stimulates the release of aldosterone, another hormone, fro…
Why is there a shortage of losartan in the US?
Apr 11, 2022 · Losartan potassium oral tablet, Zydus, 50 mg, bottle, 1000 count, NDC 68382-0136-10 Reason for the Shortage Beginning in mid-2018, FDA found that several angiotensin II receptor blocker (ARB) medicines contained nitrosamine impurities and have been recalled because they do not meet FDA's safety standards.
Why is losartan on back order?
Mar 14, 2022 · Sandoz recalled one lot of losartan and hydrochlorothiazide 100 mg/25 mg tablets in 1000 count bottles in November 2018 due to an impurity found in the active pharmaceutical ingredient. Additional information can be found at https://www.fda.gov/Safety/Recalls/ucm625492.htm. Sandoz discontinued all losartan and …
What happened to losartan potassium?
Sep 17, 2021 · On September 13, 2021, Jubilant Cadista Pharmaceuticals announced a market withdrawal of all unexpired lots of Losartan Potassium as well as Losartan Potassium and Hydrochlorothiazide distributed under the Cadista label. This market withdrawal is being carried out due to the presence of a potential azido impurity, 5- (4'- (azidomethyl)- [1,1'-biphenyl]-2yl) …
Where can I buy losartan tablets?
Apr 11, 2022 · We understand that stock of losartan with hydrochlorothiazide is limited. Stock of losartan potassium is likely to be available until early December. We are advised that the supply issue will likely be resolved by late January 2022. We are in communication with the supplier, Teva, about this issue. Check the Schedule for pharmacodes (external link)
Is losartan still on recall in 2021?
PD-Rx Pharmaceuticals Inc. is recalling 576 bottles of losartan potassium tablets because they contain trace amounts of the nitrosamine impurity NMBA, according to the May 5, 2021, US Food and Drug Administration (FDA) Enforcement Report.
Is losartan being taken off the market?
On September 13, 2021, Jubilant Cadista Pharmaceuticals announced a market withdrawal of all unexpired lots of Losartan Potassium as well as Losartan Potassium and Hydrochlorothiazide distributed under the Cadista label.Sep 17, 2021
When will losartan be available again?
Teva has losartan and hydrochlorothiazide tablets on back order and the company estimates a release date in late-April 2022.Feb 11, 2019
Is there a problem with losartan?
The most common possible side effects of losartan include dizziness, stuffy nose, back pain, chest pain, diarrhea, high potassium levels, low blood pressure, low blood sugar, and tiredness (FDA, 2018-a).
Is losartan back in stock?
Estimated Resupply Dates Major has losartan 25 mg and 100 mg tablets in unit-dose packages on back order and the company estimates a release date in early-April 2022. The 50 mg tablets in unit-dose packages are on back order and the company estimates a release date in mid-March 2022.
Is losartan still on recall 2020?
The affected lots of the voluntary recall by Legacy Pharmaceutical Packaging are the following: NDC 68645-494-54, losartan potassium tablets USP 50 mg, 30 count, Legacy Lot 180190, expires on 10/2020. NDC 68645-494-54, losartan potassium tablets USP 50 mg, 30 count, Legacy Lot 180191, expires on 10/2020.Sep 25, 2019
What can I take instead of losartan?
Hydrochlorothiazide.Metoprolol.Atenolol.Norvasc.Carvedilol.Furosemide.
What is a good replacement for losartan?
Olmesartan is available in convenient combination tablets: olmesartan/HCTZ and olmesartan/amlodipine/HCTZ. Olmesartan is better than losartan at lowering blood pressure and generally provides good 24-hour coverage.Mar 15, 2019
Is losartan on the recall list?
In November, the FDA announced a voluntary recall of losartan potassium/hydrochlorothiazide, 100 mg/25 mg tablets in 1,000-count plastic bottles, NDC 0781-5207-10, Lot number JB8912, Exp. Date 06/2020.
Can I take vitamin D with losartan?
Interactions between your drugs No interactions were found between losartan and Vitamin D3. However, this does not necessarily mean no interactions exist. Always consult your healthcare provider.
Is there a recall on losartan 2022?
Sandoz Canada and Sanis Health are recalling all lots of prescription losartan tablets due to the presence of an azido impurity above the acceptable limit. The impurity is a mutagen and can create a heightened cancer risk over time if allowed to rise above certain levels.Sep 17, 2021
Reason for the Shortage
Beginning in mid-2018, FDA found that several angiotensin II receptor blocker (ARB) medicines contained nitrosamine impurities and have been recalled because they do not meet FDA's safety standards.
Estimated Resupply Dates
Alembic has losartan and hydrochlorothiazide tablets in 90-count presentations available. The 100 mg/12.5 mg tablets and 100 mg/25 mg tablets in 1,000-count bottles are on back order and the company cannot estimate a release date. All other presentations are on intermittent back order and the company is releasing supplies as they become available.
Updated
Updated October 8, 2021 by Leslie Jensen, PharmD, Drug Information Specialist. Created February 11, 2019 by Leslie Jensen, PharmD, Drug Information Specialist. © 2021, Drug Information Service, University of Utah, Salt Lake City, UT.
All-at-once (stat) dispensing removed
Since 1 December 2021, the following presentations were put on monthly dispensing.
Availability
We are advised that the 50 mg presentation may be in short supply. We have received clinical advice that 2 x 25 mg tablets is a suitable alternative. We understand there is sufficient supplies of 25 mg tablets to cover this.
Why did Losartan withdraw from the market?
Recently, the company voluntarily withdrew some batches of Losartan from the market because they contained traces of an impurity at levels that the Food and Drug Administration (FDA) consider unsafe. On January 3, 2019, the company first announced. Trusted Source.
Is Losartan a hepatotoxic drug?
According to the National Library of Medicine, NDEA is a hepatotoxic agent, which means that it damages the liver.
What is a notice from manufacturers to the FDA about impending or current drug shortages?
Notice from manufacturers to the FDA about impending or current drug shortages allows the FDA to work with the manufacturers to prevent a drastic shortage. Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah, provided by ASHP as its exclusive authorized distributor, and used with permission.
How does drug shortage affect health?
Besides the lack of effective drug treatment, many other areas of medical care can be impacted, including medical procedure delays, treatment protocol delays, rates of medication errors, patient health outcomes, and cost. Notice from manufacturers to the FDA about impending or current drug shortages allows the FDA to work with the manufacturers to prevent a drastic shortage.
Does the University of Utah make warranties?
ASHP and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information, and specifically disclaim all such warranties.
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