The FDA enforcement report lists a Class II recall, dated 16 September, of fentanyl citrate 1,000 micrograms in 100 mL (10 micrograms/mL) in 0.9% sodium chloride infusion bags from a US supplier. The reason given is labelling: a complaint on 31 August noted that the expiry dates printed on the bag differed from the product's stated expiry. The recall is listed as ongoing.
This is a labelling action, not a reported finding about the drug's sterility or strength. Class II means use may cause temporary or reversible harm, or that serious harm is unlikely. The product is a US-distributed ready-to-use bag; whether it reaches Indian hospitals is unknown. The general lesson, checking every expiry date on premixed opioid infusions, applies everywhere.
- Check every expiry date printed on premixed opioid infusion bags before hanging them.
- If dates on a bag conflict, quarantine it and contact pharmacy.
- US units should check stock against the FDA enforcement report.
- Report labelling discrepancies through your local incident system.
Why it matters
Premixed high-concentration opioid bags leave little room for labelling errors to go unnoticed.
Don't overread it
The recall is for a labelling discrepancy, not a reported problem with sterility or potency.
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