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Valsartan Recall: Blood pressure drug affected by impurity

The Medicines and Healthcare products Regulatory Agency’s (MHRA) announced on July 5, 2018 a valsartan recall in Europe. The reason for this is an impurity at the Chinese manufacturer Zhejiang Huahai Pharmaceutical.

Valsartan is a frequently prescribed drug in hypertension treatment. In many European countries like Denmark, Germany, Finland, Hungary, or the United Kingdom the Valsartan recall has already started. Companies like 1 A Pharma, Dexcel, Heumann, Hormosan, Stada, and Zentiva recall their products. See a full list of affected companies below.

Is the valsartan impurity carcinogenic?

The contaminant is allegedly N-nitrosodimethylamine. The International Agency for Research on Cancer (IARC) and the EU classified the substance as "probably carcinogenic".

What is N-nitrosodimethylamine?

Toxicology has been researching on N-nitrosodimethylamine (NDMA) and its effects on animals and human beings. Animal studies have shown that most N-nitrosodimethylamine have a carcinogenic effect after oral ingestion or inhalation. A special feature is the limited organ specificity of their effect - in the case of N-nitrosodimethylamine, which was discovered in valsartan of the Chinese manufacturer, it affects organs like the bladder, liver, kidneys upper gastrointestinal tract, and respiratory tract.
NDMA can sometimes also be found in food. However, the amount is so minor that it is totally harmless. The average intake via food is 0.3 micrograms per day. In the recalled pills up to 22 micrograms of NDMA were found.

Discontinuing Valsartan

The Federal Institute advises to not discontinue Valsartan-containing medicines without consulting your doctor. Currently, the health risk of discontinuing is much higher than the one of the impurity.

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Precautionary Valsartan Recall

It is not yet known if and to what extent the contamination is found in the medicinal products. Thus, the recall of all batches affected in Europe is precautionary.
According to their website, the Chinese manufacturer also produces other similar blood pressure medicines, such as Irbesartan or Telmisartan. However, the authority emphasizes that "no acute patient risk" exists.
Currently, the European Medicines Agency (EMA) is investigating if drugs with similar chemical composition are also affected.

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These companies recall their products

Valsartan Recall: Mono Preparation

These Mono Preparation are affected by the Valsartan recall.

1 A Pharma (Mono)

  • Preparation (PZN): 07581224, 07581276, 07581649, 07581655, 07581974, 07582028, 07582057, 07582063, 07582092 and 07582100
  • Effective Strength: 40, 80, 160 and 320 mg
  • Pack Size: 28, 56 and 98 Pills
  • Batches: All

AAA Pharma (Mono)

  • Preparation (PZN): 08878989, 07553104, 07553110, 07553127, 07553133, 07553222, 07553239, 07630514, 07630520 and 07630537
  • Effective Strength: 40, 80, 160 and 320 mg
  • Pack Size: All
  • Batches: All

Abz Pharma (Mono)

  • Preparation (PZN): 07607656, 07608207, 07608236, 07608288, 07608302, 07608325, 07608331, 07608360, 07608377, 07608822 and 07608839
  • Effective Strength: 40, 80, 120, 160 and 320 mg
  • Pack Size: All
  • Batches: All

Actavis (Mono)

  • Preparation (PZN): 558615; 086815, 262215, 440514, 492014
  • Effective Strength: 80 and 320 mg
  • Pack Size: 80 mg: 28 Pills; 320 mg: 28, 56 and 98 Pills
  • Batches: 80 mg: 558615; 320mg: 086815, 262215, 440514, 492014

AI (Mono)

  • Preparation (PZN): 07758349, 07758378, 07758409, 07758438 and 07758349
  • Effective Strength: 40, 80, 160 and 320 mg
  • Pack Size: 40 mg: 28 Pills; 80, 160 and 320 mg: 98 Pills
  • Batches: 74042, 72293, 73918, 64315, 72325V, 73338, 81350, 72366, 72870, 72733

CT (Mono)

  • Preparation (PZN): 07586121, 07586138, 07586144, 07586150 and 07586167
  • Effective Strength: 120 and 160 mg
  • Pack Size: All
  • Batches: All

Dexcel (Mono)

  • Preparation (PZN): 09295310 and 09295379
  • Effective Strength: 80 and 160 mg
  • Pack Size: 98 Pills
  • Batches: 1603145, 1605261, 1609020, 1609027

Hennig (Mono)

  • Preparation (PZN): 09066615, 09066621, 09067201, 09067218, 09067224, 09067230, 09067247, 09067276, 09067282, 09067299 and 09067307
  • Effective Strength: 40, 80, 160 and 320 mg
  • Pack Size: All
  • Batches: All

Heumann (Mono)

  • Preparation (PZN): 10830004, 08850838, 08850844, 08850850, 08850867, 08850873, 08850896, 08850904, 08850910 and 08850927
  • Effective Strength: 40, 80, 160 and 320 mg
  • Pack Size: 28, 56 and 98 Pills
  • Batches: All

Hexal (Mono)

  • Preparation (PZN): 07607001, 07607018, 07607024, 07607030, 07607047, 07607053, 07607076, 07607082, 07607099 and 07607107
  • Effective Strength: 40, 80, 160 and 320 mg
  • Pack Size: 28, 56 and 98 mg
  • Batches: 40 mg: All Batches mit Verwendbarkeitsdatum bis 03/2020; 80 and 160 mg: All Batches mit Verwendbarkeitsdatum bis 02/2021; 320 mg: All Batches mit Verwendbarkeitsdatum bis 03/2021

Puren (Mono)

  • Preparation (PZN): 11306357, 11306363, 11306386, 11306392, 11306400, 11306417, 11306423, 11306446, 11306469, 11306475, 11306506, 11306512 and 11306529
  • Effective Strength: 40, 80, 160 and 320 mg
  • Pack Size: All
  • Batches: All

Ratiopharm (Mono)

  • Preparation (PZN): 06906167, 06906173, 06906227, 06906233, 06906285, 06906316, 06906339, 06906345, 06906368, 06906374, 06906380, 06906397, 06906405, 06906411 and 06906428 m
  • Effective Strength: 40, 80, 120, 160 and 320 mg
  • Pack Size: All
  • Batches: All

Stada (Mono)

  • Preparation (PZN): 07778228, 07778257, 07778263, 07778292, 07778300, 07778323, 07778346, 07778369, 07778375 and 07778381
  • Effective Strength: 40, 80, 160 and 320 mg
  • Pack Size: 28, 56 and 98 Pills
  • Batches: 40 mg: 70631, 74042; 80 mg: 70489, 72293, 73920, 70489, 72293, 73211, 73918; 160 mg: 73337, 74243, 81352, 73337, 74244, 81352, 64315, 72325V, 73337, 74244; 320 mg: 64361, 72366, 72870

Zentiva (Mono)

  • Preparation (PZN): 08440313, 08440359, 08440365, 08440371, 08440419, 08440431, 08440460, 08440477, 08440603 and 08440744
  • Effective Strength: 40, 80, 160 and 320 mg
  • Pack Size: All
  • Batches: All

Valsartan plus Hydrochlorothiazide

Due to the Valsartan recall the following products are taken back.

1 A Pharma plus (Combi)

  • Preparation (PZN): 07580710, 07580756, 07580762, 07580779, 07581023, 07581046, 07581052, 07581069, 07581075, 07581081, 07581098, 07581106, 07581112, 07581129 and 07581135
  • Effective Strength: 80/12,5, 160/12,5, 160/25, 320/12,5 and 320/25 mg
  • Pack Size: 28, 56 and 98 Pills
  • Batches: All

Comp. AbZ (Combi)

  • Preparation (PZN): 07608383, 07608414, 07608437, 07608466, 07608472, 07608489, 07608495, 07608503, 07608532, 07608791 and 07608816
  • Effective Strength: 80/12,5, 160/12,5, 160/25, 320/12,5 and 320/25 mg
  • Pack Size: All
  • Batches: All

Valsartan/HCT AL (Combi)

  • Preparation (PZN): 07758504, 07758533 and 07758616
  • Effective Strength: 160/12,5, 160/25 and 320/25 mg
  • Pack Size: 98 Pills
  • Batches: 70414, 73427, 64583, 74195, 71348

Comp. Basics (Combi)

  • Preparation (PZN): 08472000, 08472052, 07762115, 08472135, 08472589, 07762121, 08472075, 08472081 and 07762138
  • Effective Strength: 80/12,5, 160/12,5 and 160/25 mg
  • Pack Size: 28, 56 and 98 mg
  • Batches: 80 mg/12,5 mg: 2747047, 2779990, 2809127, 2881210, 2881210A, 2881210B; 160 mg/12,5 mg: 2751697, 2768857, 2788251, 2839490, 2839490A, 2839490B, 2892567, 2907521; 160 mg/25 mg: 2747039, 2839503, 2839507, 2839509, 2839509A, 2839509B

Comp.-CT (Combi)

  • Preparation (PZN): 07586210, 07586227, 07586233, 07586285, 07586291, 07586316, 07586345, 07709428, 07709440 and 07709486
  • Effective Strength: 80/12,5, 160/12,5, 160/25 and 320/25 mg
  • Pack Size: All
  • Batches: All

Hennig plus HCT (Combi)

  • Preparation (PZN): 09067336, 09067342, 09067359, 09067365, 09067371, 09067388, 09067394, 09067402, 09067419, 09067425, 09067431, 09067448, 09067454, 09067460 and 09067477
  • Effective Strength: HCT 80/12,5, 160/12,5, 160/25, 320/12,5 and 320/25 mg
  • Pack Size: All
  • Batches: All

Hexal comp. (Combi)

  • Preparation (PZN): 07607113, 07607136, 07607188, 07607194, 07607231, 07607248, 07607254, 07607260, 07607277, 07607283, 07607308, 07607314, 07607320, 07607337 and 07607343
  • Effective Strength: 80/12,5, 160/12,5, 160/25, 320/12,5 and 320/25 mg
  • Pack Size: 28, 56 and 98 Pills
  • Batches: 80/12,5, 160/12,5, 160/25 and 320/12,5 mg: All Batches mit Verwendbarkeitsdatum bis 01/2021; 320/25 mg: All Batches mit Verwendbarkeitsdatum bis 03/2021

Hormosan (Combi)

  • Preparation (PZN): 09289137, 09289166, 09289172, 09289195, 09289226 and 09289232
  • Effective Strength: 80/12,5, 160/12,5 and 160/25 mg
  • Pack Size: 28 and 98 Pills
  • Batches: All

Comp. Puren (Combi)

  • Preparation (PZN): 11358414, 11358420, 11358437, 11358443, 11358472, 11358489, 11358495, 11358526, 11358532, 11358549, 11358555, 11358561, 11358578, 11358584, 11358590, 11358609 and 11358615
  • Effective Strength: 80/12,5, 160/12,5, 160/25, 320/12,5 and 320/25 mg
  • Pack Size: All
  • Batches: All

Ratiopharm (Combi)

  • Preparation (PZN): 06906440, 06906500, 06906523, 06906546, 06906569, 06906581, 06906612, 06906629, 06906635, 06906658, 06906670, 06906730, 06906753 and 06906842
  • Effective Strength: 80/12,5, 160/12,5, 160/25, 320/12,5, and 320/25 mg
  • Pack Size: All
  • Batches: All

Valsartan/HCT Stada (Combi)

  • Preparation (PZN): 07778412, 07778441, 07778458, 07778470, 07778501 and 07778530
  • Effective Strength: 80/12,5, 160/12,5, 160/25, 320/12,5 and 320/25 mg
  • Pack Size: 28 and 98 Pills
  • Batches: 80/12,5 mg: 70342; 160/12,5 mg: 70410, 73426; 160/25 mg: 70584, 73392, 74195; 320/12,5 mg: 71319, 81141; 320/25 mg: 70943, 71348, 73861, 81270, 81271

Zentiva Comp. (Combi)

  • Preparation (PZN): 08409421, 08409438, 08409444, 08409450, 08409467, 08409473, 08409496, 08409510, 08409527, 09123678, 09123684, 09123690, 09123715, 09123721 and 09123738
  • Effective Strength: 80/12,5, 160/12,5, 160/25, 320/12,5 and 320/25 mg
  • Pack Size: All
  • Batches: All

(The list of affected drugs comes from the German Pharmacy Newspaper (DAZ).)

About Valsartan

Valsartan is an active ingredient in the AT1 receptor antagonist. Valsartan is used for the treatment of hypertension as well as mild to moderate heart failure.
Moreover, Valsartan is the second most frequently prescribed medication in its drug group. Valsartan has a total of 717 million daily treatment doses (DDD), which is just behind Candesartan (around DDD 1 billion) and followed by Losartan (about DDD 138 million) according to the Drug Prescribing Report.
The substance is found in countless drugs either as a single substance or in combination preparations.

Related problems

The problem behind such an affair as Valsartan recall is often related to the production chains of popular drugs and drugs which are no longer patented. They are being transferred to emerging and developing countries, where the production is then taken over by subcontractors. In 2015 a similar case happened. The company GVK Biosciences did not sufficiently conduct safety studies. As a result, the European Medicines Agency (EMA) has reviewed over one thousand drug approvals with active ingredients from India. Medicines that were affected at that time are also antihypertensive drugs, but also antiallergic drugs or gastric protective agents.

Not affected by valsartan recall

Some pharmaceutical companies have already announced that they have not been contacted by Valsartan recall.

Companies not affected by the recall:

  • Aurobindo
  • Maylan Dura
  • Novartis
  • TAD Pharma

Novartis announced that its valsartan-containing medicines meet the quality standards and are not affected by valsartan recall. Novartis manufactures the following products in group production in Ireland and Switzerland:

  • Entresto®
  • Exforge® and Exforge HCT®
  • Diovan®
  • Codiovan®
  • Dafiro® and Dafiro HCT®
  • Provas® and Provas® Comp.

The pharmaceutical group TAD Pharma also does not purchase the active ingredient from the affected Chinese manufacturer. These are the following preparations:

  • Valsacor®
  • Valsacor® Comp.

Also Mylan Dura, partner of Barmer, is not affected by the Valsartan recall. Mylan Dura obtains the active ingredient from India.

Ibersartan recall

The German pharmaceutical company Hormosan Pharma GmbH announced an Ibersartan recall. Ibersartan is a related active substance of Valsartan and also belongs to the group of AT1 antagonists. The company said that it could not be ruled out that the product is also contaminated.

Irbesartan Hormosan

  • Effective Strength: 150 and 300 mg
  • Pack Size: 28, 56 and 98 Pills
  • Batches: H503986, H504180, H504180A, H504180B, H603064, H602847

Losartan recall

So far, there has been no recall of Losartan.

Here is a summary on the companies affected by the Valsartan recall and those, which do not obtain the active substance from the Chinese manufacturer Zhejiang Huahai Pharmaceutical:

Company Mono Combi not affected
1 A Pharma ✓ ✓
AAA Pharma ✓
Abz Pharma ✓ ✓
Actavis ✓
AI ✓
AL ✓
Basics ✓
CT ✓ ✓
Dexcel ✓
Hennig ✓ ✓
Heumann ✓
Hexal ✓ ✓
Hormosan ✓
Mylan Dura ✓
Novartis ✓
Puren Pharma ✓ ✓
Ratiopharm ✓ ✓
Stada ✓ ✓
TAD Pharma ✓
Zentiva ✓ ✓

Get to know more about blood pressure and the various blood pressure tablets.

Click here for more information from the German Federal Institute for Drugs and Medical Devices (BfArM).

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