Prefilled 12 mL oral syringes of ibuprofen suspension, 150 mg per 7.5 mL, from a repackager are under an as-yet unclassified recall for cross-contamination with other products. The recall is ongoing.
Prefilled unit-dose syringes are used precisely because they remove the two steps where paediatric liquid dosing goes wrong - reading the concentration and drawing up the volume. Cross-contamination in that supply chain means an infant may receive a dose of something nobody intended and nobody would suspect, since the syringe carries an ibuprofen label.
The practical step is to check whether your inpatient or day-unit supply comes from a repackager rather than the manufacturer, since that is the part of the chain affected. For an individual child, consider a repackaged syringe as a possible explanation for an unexplained reaction after a dose of ibuprofen, and keep the syringe rather than discarding it.
- Check whether unit-dose oral syringes on your unit come from a repackager, and identify the affected lots with pharmacy
- Keep the device when investigating an unexpected reaction after a liquid dose - it is the only evidence of what was given
- Report suspected product defects through the national pharmacovigilance route
- Where prefilled syringes are withdrawn, restate the concentration in the prescription, since staff will revert to drawing up from a bottle
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