Biznes Fakty
Apap Extra Series Discontinued. GIF Announcement
The Chief Pharmaceutical Inspector has made the decision to promptly withdraw a specific batch of the well-known painkiller Apap Extra from circulation. The rationale, as noted in the announcement, pertains to contamination by a „foreign body” during the production of the specified batch.
This action pertains to batch U1508501 of the medication Apap Extra (Paracetamolum + Coffeinum) 500 mg + 65 mg, packaged in a box containing 10 film-coated tablets, with an expiration date of October 2027.
The producer of this medication is US Pharmacia Sp. z o. o. located in Wrocław.
GIF decision
The Chief Pharmaceutical Inspector’s statement indicates that „the contamination with a foreign body occurred during the unloading of the granulate due to a breach in the seal of the granulator discharge valve.”
„Based on the footage from surveillance cameras that confirmed no irregularities during the process, the likelihood of a quality defect in the Apap Extra batch that was produced before the seal of the granulator discharge valve was compromised was excluded,” it was reported.
„Following the risk assessment conducted, the responsible entity advised withdrawing the specific batch (number U1508501 – ed.) from sale,” the report stated.
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The urgency of immediate enforceability
GIF has enforced the decision to withdraw the product with immediate effect, emphasizing the necessity to safeguard human health and life. It was highlighted that the presence of a foreign body in the medication could pose a risk to patients.
A request for comment has been sent to the manufacturer. As of the time of publication, no response has been received.
