GIF recalled 35 drugs. In the list of contaminated preparations Ibuprofen and Paracetamol

ByValeska
GIF recalled 35 drugs. In the list of contaminated preparations Ibuprofen and Paracetamol

Today, the Main Pharmaceutical Inspectorate issued 11 notifications regarding the withdrawal of medicinal products from the market.

Most of the products withdrawn from sale were manufactured by B. Braun Melsungen, a German pharmaceutical company. Why did the General Inspectorate make such a decision? Get to know the details of the provisions.

Ibuprofen and Paracetamol for infusion withdrawn from sale

Ibuprofen B. Braun and Paracetamol B. Braun, sold in the form of a solution for infusion, were withdrawn from sale. According to the Main Pharmaceutical Inspectorate, trace amounts of midazolam were found in some batches of drugs, which oscillate above the permitted daily exposure and may cause allergic reactions, although the risk is assessed as low. Due to this threat, GIF decided to withdraw the following medicinal products:

Ibuprofen B. Braun (Ibuprofen), solution for infusion, 600 mg/100 ml

  • package content: 20 bottles of 100 ml,

  • GTIN number: 05909991396725,

  • serial number: 20511406,

  • expiry date: 30/11/2023.

Ibuprofen B. Braun (Ibuprofen), solution for infusion, 600 mg/100 ml

  • package content: 20 bottles of 100 ml,

  • GTIN number: 05909991396725,

  • serial number: 22037415,

  • expiry date: 31/12/2024.

Ibuprofen B. Braun (Ibuprofen), solution for infusion, 600 mg/100 ml

  • package content: 20 bottles of 100 ml,

  • GTIN number: 05909991396725,

  • serial number: 22096402,

  • expiry date: 02/28/2025.

Ibuprofen B. Braun (Ibuprofen), solution for infusion, 600 mg/100 ml

  • package content: 20 bottles of 100 ml,

  • GTIN number: 05909991396725,

  • serial number: 22171402,

  • expiry date: 31/03/2025.

Ibuprofen B. Braun (Ibuprofen), solution for infusion, 600 mg/100 ml,

  • package content: 20 bottles of 100 ml,

  • GTIN number: 05909991396725,

  • serial number: 22172407,

  • expiry date: 31/03/2025.

Ibuprofen B. Braun (Ibuprofen), solution for infusion, 400 mg/100 ml

  • package content: 20 bottles of 100 ml,

  • GTIN number: 05909991396701,

  • serial number: 21016406,

  • expiry date: 31/12/2023.

Ibuprofen B. Braun (Ibuprofen), solution for infusion, 400 mg/100 ml

  • package content: 10 bottles of 100 ml,

  • GTIN number: 05909991396695,

  • serial number: 21183410,

  • expiry date: April 30, 2024,

Ibuprofen B. Braun (Ibuprofen), solution for infusion, 400 mg/100 ml

  • package content: 20 bottles of 100 ml,

  • GTIN number: 05909991396701,

  • serial number: 21183410,

  • expiry date: 04/30/2024.

Ibuprofen B. Braun (Ibuprofen), solution for infusion, 400 mg/100 ml

  • package content: 20 bottles of 100 ml,

  • GTIN number: 05909991396701,

  • serial number: 21183411,

  • expiry date: 04/30/2024.

Ibuprofen B. Braun (Ibuprofen), solution for infusion, 400 mg/100 ml

  • package content: 20 bottles of 100 ml,

  • GTIN number: 05909991396701,

  • serial number: 21266401,

  • expiry date: 30/06/2024.

Ibuprofen B. Braun (Ibuprofen), solution for infusion, 400 mg/100 ml

  • package content: 20 bottles of 100 ml,

  • GTIN number: 05909991396701,

  • serial number: 21391412,

  • expiry date: 08/31/2024.

Ibuprofen B. Braun (Ibuprofen), solution for infusion, 400 mg/100 ml

  • package content: 20 bottles of 100 ml,

  • GTIN number: 05909991396701,

  • serial number: 21434403,

  • expiry date: 30/09/2024.

Ibuprofen B. Braun (Ibuprofen), solution for infusion, 400 mg/100 ml

  • package content: 20 bottles of 100 ml,

  • GTIN number: 05909991396701,

  • serial number: 21435406,

  • expiry date: 30/09/2024.

Ibuprofen B. Braun (Ibuprofen), solution for infusion, 400 mg/100 ml

  • package content: 20 bottles of 100 ml,

  • GTIN number: 05909991396701,

  • serial number: 22037414,

  • expiry date: 31/12/2024.

Ibuprofen B. Braun (Ibuprofen), solution for infusion, 400 mg/100 ml,

  • package content: 20 bottles of 100 ml,

  • GTIN number: 05909991396701,

  • serial number: 22096401,

  • expiry date: 02/28/2025.

Ibuprofen B. Braun (Ibuprofen), solution for infusion, 400 mg/100 ml

  • package content: 20 bottles of 100 ml,

  • GTIN number: 05909991396701,

  • serial number: 22133402,

  • expiry date: 02/28/2025.

Ibuprofen B.Braun (Ibuprofen), solution for infusion, 400mg/100ml

  • package content: 20 bottles of 100 ml,

  • GTIN number: 05909991396701,

  • serial number: 22134402,

  • expiry date: 02/28/2025.

Ibuprofen B.Braun (Ibuprofenum), solution for infusion, 400mg/100ml,

  • package content: 20 bottles of 100 ml,

  • GTIN number: 05909991396701,

  • serial number: 22171401,

  • expiry date: 31/03/2025.

Paracetamol B.Braun (Paracetamolum), solution for infusion, 10mg/ml

  • package content: 10 bottles of 50 ml,

  • GTIN number: 05909990992072,

  • serial number: 21361402,

  • expiry date: 31/08/2023.

Paracetamol B.Braun (Paracetamolum), solution for infusion, 10mg/ml

  • package content: 10 bottles of 50 ml,

  • GTIN number: 05909990992072,

  • serial number: 21421402,

  • expiry date: 30/09/2023.

Paracetamol B.Braun (Paracetamolum), solution for infusion, 10mg/ml

  • package content: 10 bottles of 50 ml,

  • GTIN number: 05909990992072,

  • serial number: 21421403,

  • expiry date: 30/09/2023.

Paracetamol B.Braun (Paracetamolum), solution for infusion, 10mg/ml

  • package content: 10 bottles of 50 ml,

  • GTIN number: 05909990992072,

  • serial number: 21507412,

  • expiry date: November 30, 2023,

Paracetamol B.Braun (Paracetamolum), solution for infusion, 10mg/ml

  • package content: 10 bottles of 50 ml,

  • GTIN number: 05909990992072,

  • serial number: 21507413,

  • expiry date: 30/11/2023.

The entity responsible for the production of the batches indicated is B. Braun Melsungen AG, Carl-Braun-Straße 1, 34212 Melsungen (Germany). The decision is immediately enforceable. Paracetamol and Ibuprofen in the form of a solution have antipyretic, anti-inflammatory and analgesic effects. They are administered to adult patients who, for various reasons, cannot take medicines in other forms.

Not only Ibuprofen and Paracetamol. What other drugs is GIF withdrawing from pharmacies?

The Main Pharmaceutical Inspectorate decided to withdraw from sale throughout the country also other drugs produced by the B. Braun Melsungen concern. The list included:

  • Amikacin B.Braun (Amikacinum), solution for infusion (at a concentration of 10, 5 and 2.5 mg / ml) – used in the case of severe infections of the body (for example, peritonitis or post-burn infection of wounds),
  • Fluconazole B. Braun (Fluconazole)solution for infusion, (2mg / ml) – used, among others, in yeast infection of the mucous membranes,
  • Gentamicin B. Braun (Gentamicinum), solution for infusion, (at a concentration of 1 and 3 mg / ml) – prescribed to patients who are struggling with severe and complicated infections, including within the urinary tract,
  • Metronidazoles B.Braun (Metronidazolum)solution for infusion (5mg/ml) – treats infections caused by anaerobic bacteria.

The reason for the recall of the pharmaceuticals was, as in the case of Paracetamol and Ibuprofen, contamination of the solutions with midazolam.

Source: GIF

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