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Regulatory · 04 of 06

Recall: ibuprofen 150 mg/7.5 mL oral syringes for cross-contamination

Check with pharmacy for Safecor ibuprofen 150 mg/7.5 mL oral syringes and remove affected lots from ward stock.

The FDA enforcement report lists an ongoing recall, dated 2 September and not yet classified, of ibuprofen oral suspension 20 mg/mL supplied as 7.5 mL (150 mg) doses in 12 mL oral syringes, berry flavour, repackaged by Safecor Health. The stated reason is cross-contamination with other products.

The report does not name the contaminating products or any harm. Unit-dose oral syringes like these are used mainly in hospital wards, so the practical exposure is in inpatient paediatric settings rather than in homes. Until the FDA classifies the recall, its seriousness is not established. This is a US action; Indian products are not affected as far as the record shows.

  • Ask pharmacy whether these unit-dose syringes are stocked on paediatric wards
  • Quarantine affected lots and use alternative supplies
  • Report any unexpected reaction after a dose from these syringes

Why it matters

Unit-dose oral syringes go straight to children on wards, so a contamination recall needs a local stock check.

Don't overread it

The recall is not yet classified, and no harm has been reported.

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