The FDA lists a Class II recall of buprenorphine hydrochloride injection 0.3 mg/mL in 1 mL single-dose vials, five per pack. The reason given is crystallisation, and the recall status is ongoing. The firm named is Par Health USA.
A Class II recall means use may cause temporary or medically reversible harm, or that serious harm is unlikely. The notice gives no details of reported patient harm. It concerns the US market.
The CDSCO position and Indian availability of this product are not stated in the notice, so check your own stock and supplier. Crystals in an injectable are visible, so inspect any vial before drawing it up.
- Check the NDC and lot against the FDA notice if you stock this US product.
- Inspect injectable vials for crystals or particles before use and do not use any that look abnormal.
- Report suspected product defects through your local pharmacovigilance route.
- Have an alternative analgesic or opioid-substitution plan ready if stock is quarantined.
Why it matters
A defect in a parenteral opioid is easy to miss unless someone checks the vial.
Don't overread it
A Class II recall is a quality action, not a finding of patient harm, and the notice concerns US distribution.
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