A popular product is disappearing from pharmacies. Guilty quality defect

The Main Pharmaceutical Inspector issued a decision to withdraw the pharmaceutical raw material – glycerin 85% from the market. The decision issued on April 8 is immediately enforceable. The reason for the recall is a quality defect.

  1. GIF decided to withdraw the pharmaceutical raw material – glycerin 85 percent from pharmacies.
  2. The reason for the recall was a quality defect
  3. A total of 20 product series have been discontinued – see the exact list below
  4. More information can be found on the Onet homepage

Glycerin withdrawn from pharmacies – name and batch number

The Main Pharmaceutical Inspector decided to withdraw from the market the pharmaceutical raw material – glycerin 85 percent throughout the country. The entity responsible is Zakład Farmaceutyczny Amara Sp. z o. o

What series have been discontinued?

Glycerin 85%, Glycerolum (85%), op. 100 g

  1. batch number: 150721 expiry date: 06.2023
  2. batch number: 150721 B expiry date: 06.2023
  3. batch number: 150721 C expiry date: 06.2023
  4. batch number: 150721 D expiry date: 06.2023
  5. batch number: 150721 F expiry date: 06.2023
  6. batch number: 150721 H expiry date: 06.2023
  7. batch number: 150721 and expiry date: 06.2023
  8. batch number: 150721 J Expiry date: 06.2023

Glycerin 85%, Glycerolum (85%), op. 250 g

  1. batch number: 150721 E expiry date: 06.2023
  2. batch number: 150721 F expiry date: 06.2023
  3. batch number: 150721 H expiry date: 06.2023
  4. batch number: 150721 J Expiry date: 06.2023
  5. batch number: 150721K expiry date: 06.2023

Glycerin 85%, Glycerolum (85%), op. 500 g

  1. batch number: 150721 C expiry date: 06.2023
  2. batch number: 150721 D expiry date: 06.2023
  3. batch number: 150721 G expiry date: 06.2023
  4. batch number: 150721 J Expiry date: 06.2023

Glycerin 85%, Glycerolum (85%), op. 1000 g

  1. batch number: 150721 D expiry date: 06.2023
  2. batch number: 150721 G expiry date: 06.2023
  3. batch number: 150721 J Expiry date: 06.2023

Glycerin – why was it withdrawn?

«The Main Pharmaceutical Inspectorate received information from the MAH Amara Sp. z o. o. with its seat in Kraków on the grounds for withdrawal from the market of the pharmaceutical raw material GLICERYNA 85% listed in the decision. » —We read on the GIF page.

  1. Read also: Do you have a drug at home that has just been withdrawn from the market? The doctor tells you what to do

What is the reason for the withdrawal? «The MAH informed the Chief Pharmaceutical Inspector about the receipt of out-of-specification results for the parameter: sugars. The research was carried out on reference samples of pharmaceutical raw material as part of the complaint procedure. In connection with the finding of the quality defect referred to above, the Main Pharmaceutical Inspector decided to withdraw the batch of the pharmaceutical raw material in question from the market throughout the country »- informs the Inspectorate.

Glycerin – what is it used for?

85% glycerin, also known as Propanetriol, is an aqueous solution of glycerol, an organic chemical compound from the group of sugar, the simplest stable trihydric alcohol (triol). Glycerin 85% is a pharmaceutical substance with disinfecting and softening properties, facilitating the penetration of medicinal ingredients through the skin or mucous membranes. When administered orally, it has a laxative effect and stimulates intestinal peristalsis.

Pharmaceutical raw material for a pharmacy formulation used in the production of aqueous solutions for oral use, auxiliary raw material in the preparation of ointments, creams, water and spirit solutions, spirits, suspensions, gels, jellies, glues, glycerol-gelatin bases for knobs, rectal suppositories and intraurethral rods, rectal infusion solutions. A pharmaceutical raw material also used in a hospital prescription for the preparation of sterile solutions for intravenous infusion, sometimes also laxative suppositories.

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