The FDA has classified as Class II an ongoing recall by American Regent of atropine sulfate injection USP 1 mg/mL, supplied in 1 mL single-dose vials and in 25-vial packs. The stated reason is particulate contamination, identified as hair, glass and/or paraformaldehyde.
That list is worse than the classification suggests. Class II covers defects likely to cause temporary or medically reversible harm, and for an intravenous drug given as a bolus in an emergency, the practical risks are local and embolic injury and, with paraformaldehyde, chemical irritation. Atropine is not a drug anyone inspects carefully before drawing up: it is reached for during bradycardia, organophosphate poisoning and rapid sequence induction in children, in exactly the circumstances where nobody holds a vial to the light.
The action is to identify and remove affected lots from resuscitation trolleys, difficult airway kits and paediatric drug boxes rather than only from the pharmacy shelf, because that is where these vials sit unexamined for months. Check the anaesthetic room and the ambulance stock too. In India, atropine is supplied by many manufacturers and this recall concerns one US firm's lots; the transferable point is the audit, which is worth doing whether or not this recall touches your supply.
- Check resuscitation trolleys, airway kits and paediatric drug boxes, not just pharmacy stock
- Include ambulance and anaesthetic room supplies in the sweep
- Inspect vials against the light before drawing up, particularly in non-urgent use
- Class II here reflects reversible harm, but the contaminants listed warrant an urgent check
- This concerns specific US lots from one manufacturer; the audit is worth doing regardless
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