By the decision of the Chief Pharmaceutical Inspector, nine batches of the medicinal product Amotaks (Amoxicillinum) of Tarchomińskie Zakłady Farmaceutyczne “Polfa” SA will be removed from pharmacies. What was the reason for the withdrawal from the market?
These are exactly granules for the preparation of an oral suspension of 500 mg / 5 ml with the expiry date of 11.2018. The withdrawn batch numbers are:
- serial number: 011116
- serial number: 021116
- serial number: 031116
- serial number: 041116
- serial number: 071116
- serial number: 101116
- serial number: 111116
- serial number: 141116
- serial number: 181116
These series were withdrawn because they “did not meet the requirements of the quality specification in the declared shelf life in terms of the content of related substances”.
Amotax is a semi-synthetic penicillin – a broad-spectrum antibiotic used to treat bacterial infections (the drug prevents bacteria from multiplying and they die). The preparation is used in the treatment of children and adults, including acute sinusitis, otitis media, tonsillitis and pharyngitis, community acquired pneumonia, acute pyelonephritis.
Comp. on the basis of gif.gov.pl