BETHESDA, MD 10 May 2013—Japan-based Health & Life Co. Ltd. on May 8 started recalling the atomizer that delivers Asthmanefrin, a nonprescription racepinephrine hydrochloride solution, because a washer could dislodge and become a choking hazard, the drug's manufacturer said.
Asthmanefrin maker Nephron Pharmaceuticals Corporation said in a press release that the recall pertains to EZ Breathe Atomizers distributed from August 3, 2012, through April 24, 2013.
Specifically, the company said, the recall affects Asthmanefrin starter kits from lots R2029A, R2029B, R2039A, R2042A, R2045A, and R2047A; atomizers with a serial number in the range of 1206034476–1206069065, 1209069180–1209069202, 1207003710–1207038299, 1209069203–1209069460, 1207046505–1207081124, 1210000001–1210103680, 1208027421–1208062155, 1210104001–1210104044, or 1209000001–1209069179; and replacement medication cups from lots 120902, 120903, and 120904.
The drug solution, according to its "Drug Facts" label, is for use by people with asthma.
Nephron said consumers who have one of the atomizers affected by the recall should stop using the device and call 855-413-8920, 8 a.m. to 5 p.m. EDT, to return and replace it at no charge.
Distributors and customers who obtained their atomizers directly from the company are being notified by direct mail, e-mail, or telephone, Nephron said.
The company markets Asthmanefrin as an alternative to Primatene Mist, a nonprescription epinephrine inhalation aerosol whose original delivery device contains a now-banned propellant.