Popular vitamin withdrawn from trading. “A threat cannot be ruled out”

The Chief Pharmaceutical Inspector decided to withdraw from the trading of the Vitamin C medical product batch synthesis. Stains and discoloration appeared on the capsules. “A threat to human health and life cannot be ruled out,” we read in a communiqué.

The Chief Pharmaceutical Inspector was received from the subject of responsible information regarding the incompatibilities found in the archival rehearsals of the Vitamin C product (Acidum ascorbicum) 500 mg, hard capsules.

This may affect safety

It is about the presence of brown spots and discoloration on the surface of the capsules. The problem concerns the series with the number 010723 with the expiry date until July 31, 2025. The Chief Pharmaceutical Inspector decided to withdraw a defective series from trading throughout the country. The decision was given to immediate enforceability.

“The discrepancies found in the form of the presence of brown spots and discoloration on the surface of the capsules may affect the safety of the use of the medicinal product in question. Therefore, a threat to human health and human life cannot be excluded from leaving the medical product series in the subject” – reads in the justification of the decision.

The manufacturer proposed to withdraw the series

The entity responsible after finding irregularities carried out explanatory actions. They found that the defective series was covered by the stability test in 2023 and until the 12th month of the period of expiry period met the quality requirements specified for this product.

No complaint reports have been registered since the series is produced. Despite this, in connection with finding a problem with meeting quality requirements in the “appearance” parameter, the manufacturer recommended the withdrawal of the drug series from the trading in question.

GIF decided that the occurrence of such a qualitative defect requires immediate administrative proceedings.