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Recall of the antibiotic Oracefal

Recall of the antibiotic Oracefal


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In agreement with Afssaps, the Bristol-Myers Squibb laboratory is recalling lot 9J56684 from Oracefal, intended to treat ENT infections. Afssaps recommends that patients in possession of a vial bearing this lot number not to use it and to bring it back to the pharmacy. (News of 11/02/11)

  • The identification of a piece of glass in a vial of the antibiotic Oracefal ® 250 mg / 5ml, powder for oral suspension, led the Bristol-Myers Squibb laboratory, in agreement with Afssaps, to proceed with the recall of lot 9J56684 (expiry 09/2012).
  • The drug Oracefal® 250 mg / 5 ml is an antibiotic used primarily for the treatment of respiratory tract infections and ENT infections in children. The drug is administered after reconstitution with water using a measuring spoon.
  • Afssaps recommends Patients in possession of a vial bearing this lot number not to use it and to bring it back to the pharmacy. When using the bottle, it is recommended to consult a doctor as a precaution.
  • Afssaps asked the Bristol-Myers Squibb laboratory to identify the causes that led to the presence of the piece of glass found in the bottle of this lot.