British drugmaker GlaxoSmithKline was one of many companies forced to pull its version of heartburn med Zantac off shelves last year after a widespread carcinogen scare. Now, GSK is in hot water for other popular over-the-counter meds, but this time it could affect children.
GSK has voluntarily recalled multiple lots of Children's Robitussin Honey Cough and Chest Congestion DM and Children's Dimetapp Cold and Cough for missing graduation markings on some of the products' dosing cups.
The recall affects two lots of Robitussin, some of which are missing the 5- and 10-milliliter graduation lines on their dosing cups, and one lot of Dimetapp, some of which are missing the 10-milliliter marker, the FDA said.
The FDA warned that inexact dosing could lead to an overdose in children; GSK has not reported any adverse effects so far.
The recalled lots of Robitussin and Dimetapp was distributed nationwide between Feb. 5 and June 3 and carry the GSK and Pfizer brand names on their labels. The drugmakers launched their joint consumer health venture on Aug. 1.
GSK's newest recall is its first major market withdrawal since the drugmaker pulled its branded version of heartburn med Zantac after a carcinogen scare last summer.
In October, GSK recalled its version of Zantac after the FDA identified possible contamination from N-nitrosodimethylamine (NDMA), a likely human carcinogen.
The findings sparked global recalls for Zantac. The FDA launched its own mandatory recall in April after finding NDMA could build up in stored lots of the drug over time.
After the recalls, GSK has found itself on the receiving end of a potentially large legal overhang from angry consumers.
In a federal suit filed in California in October, attorneys for Walter Hantsen accused Sanofi, GlaxoSmithKline and Boehringer Ingelheim of misleading consumers about the dangers of generic and branded Zantac after they “deliberately crafted their label, marketing, and promotion” to downplay the potential health risks for patients.
A separate lawsuit in Colorado also pegged Pfizer as one of the defendants. A fifth company, Chattem, was also named in the suits.