GIF withdraws glycerin from the market

The Main Pharmaceutical Inspectorate issued a decision to withdraw several batches of the pharmaceutical raw material GLICERINE 85%. The entity responsible is Zakład Farmaceutyczny “AMARA” Sp. z o. o. The reason for the withdrawal is quality defects.

Glycerin 85% withdrawn from the market

Main Pharmaceutical Inspectorate on the basis of the MAH’s report on the suspected failure to meet the quality requirements in several series of the GLICERYNA 85% product. decided to withdraw these products from the market. As we read in the release, the basis for the notification was that the responsible entity obtained results beyond the specification in the field of aldehydes and sugars. Which series of the GLICERYNA 85 percent product? were withdrawn from the market?

Glycerin series 85 percent. withdrawn from the market

GIF announced the recall of the following series:

Glycerin 85% 100 g:

  1. Lot Number: 030819C, Expiration Date: 2021/05/31
  2. Lot Number: 030819E, Expiration Date: 2021/05/31
  3. batch number: 030819G, expiration date: 2021/05/31
  4. batch number: 040120, expiry date: 2021-10-31
  5. batch number: 040120B, expiry date: 2021-10-31
  6. Lot Number: 040120C, Expiration Date: 2021/10/31
  7. batch number: 030819, expiry date: 2021-05-31

Glycerin 85% 250 g:

  1. batch number: 030819, expiry date: 2021-05-31
  2. batch number: 030819D, expiration date: 2021/05/31
  3. Lot Number: 030819E, Expiration Date: 2021/05/31
  4. batch number: 030819G, expiration date: 2021/05/31
  5. batch number: 040120, expiry date: 2021-10-31
  6. batch number: 040120B, expiry date: 2021-10-31
  7. Lot Number: 040120C, Expiration Date: 2021/10/31

Glycerin 85% 500 g:

  1. batch number: 030819, expiry date: 2021-05-31
  2. Lot Number: 030819C, Expiration Date: 2021/05/31
  3. Lot Number: 030819F, Expiration Date: 2021/05/31
  4. batch number: 030819G, expiration date: 2021/05/31
  5. batch number: 040120, expiry date: 2021-10-31
  6. Lot Number: 040120C, Expiration Date: 2021/10/31
  7. batch number: 040120D, expiration date: 2021/10/31
  8. Lot Number: 040120E, Expiration Date: 2021/10/31

Glycerin 85% 1000 g:

  1. batch number: 030819B, expiry date: 2021-05-31
  2. Lot Number: 030819C, Expiration Date: 2021/05/31
  3. batch number: 040129B, expiry date: 2021-10-31
  4. Lot Number: 040120E, Expiration Date: 2021/10/31
  5. Lot Number: 040120F, Expiration Date: 2021/10/31

Responsible entity: Zakład Farmaceutyczny «AMARA» Sp. z o. o. The decision of the Main Pharmaceutical Inspectorate is immediately enforceable.

The editorial board recommends:

  1. Properties and application of glycerin
  2. How to take care of your hands during a pandemic?
  3. The most important information about vegetable glycerin

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