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[HEALTH] · Italy · 2 sources

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AIFA announces recall of Pfizer anti-anemia medication

The Italian Medicines Agency (AIFA) has issued a precautionary recall for a specific batch of the anti-anemia drug Lederfolin (active ingredient calcium levofolinate) 7.5 mg tablets. The recall affects batch number Z369, which has an expiration date of 30/04/2027.

The measure was taken by Pfizer Italia following a communication regarding an out-of-specification (OOS) result discovered during stability studies. Lederfolin is primarily used to treat folate-deficiency anemia and serves as an antidote or protector against the side effects of anti-tumor drugs.

Pfizer Italia has initiated the withdrawal procedure, and the NAS Nucleo of Rome has been requested to oversee the verification process.

Entities

AIFA · Lederfolin · NAS Nucleo of Rome · Pfizer Italia

Sources