Pharma company runs afoul of child-resistant packaging rules

Consumer Products Safety Commission steps into distribution of a generic form of Ambien


Drug recalls happen all the time, but it’s out of the ordinary for the recall to be caused by unit-dose packaging failing the “child resistant” requirements of the Poison Prevention Packaging Act. That flaw, for zolpidem tartarate sublingual tablets (a generic form of the Ambien sleep aid), was called out by the Consumer Products Safety Commission (CPSC)—and not the usual recall source, FDA. The manufacturer, Novel Labs, together with its sales and distribution subsidiary, Gavis Pharmaceuticals (both are business units of Lupin Group), is offering full refunds for a product lot manufactured in early 2016.

No deaths or injuries have been reported by CPSC, but Ambien (or zolpidem) has been implicated in numerous drug-overdose deaths over the years; the product also underwent a revised label and reduced dosage recommendation in 2013 due to reports of drowsiness and bizarre episodes of sleepwalking. (Ambien was introduced by Sanofi-Aventis over 20 years ago; the product went generic in 2007; there are now multiple generic makers.)

For some, all this is old news; the original recall was issued by Gavis in early May. A CPSC notification was issued on July 27; regulators like the California Board of Pharmacy (which routinely broadcasts recall notifications to the public) didn’t act on it until the later date. (However, California BoP did issue a notice to pharmacies in May.) A CPSC spokesperson says that the CPSC notification was worked out in conjunction with Novel Labs.

Child-resistant packaging is a longstanding hurdle for unit-dose packaging—blister cards and the like. Pharma manufacturers and their contract packagers have a well-understood process of testing secondary packaging to get most valued “F=1” certification for packages that are both child-resistant and “senior friendly.”  Most oral solids are dispensed in pill bottles with a cap feature that provides the child resistance and senior friendliness.