By the decision of GIF, 3 series of tablets used in the prevention and treatment of diseases caused by folic acid deficiency will disappear from pharmacies across the country.
GIF withdrew from the market throughout the country series of Acidum Folicum Richter, tablets, 5 mg, batch number: H41042A, expiry date: 01.2016, H45064A, expiry date: 05.2016, H45065A, expiry date: 05.2016.
The entity responsible is Gedeon Richter Polska sp. Z oo
The decision was made immediately enforceable.
The reason for the recall of the above-mentioned product series was the out-of-specification result, related to exceeding the chromatographic purity parameter in long-term stability studies.
Indications:
Prevention and treatment of diseases caused by folic acid deficiency. Prevention of a folate deficiency in at least the 3 months before pregnancy in women who have had a baby with a birth defect of the neural tube.
Based on: gif.gov.pl