The CPSC is seeking civil penalties from Reddy’s, saying that between 2008 and 2012 it sold prescription drugs in unit dose packaging that failed to comply with child-resistant regulations under the Poison Prevention Packaging Act and neglected to issue general certificates of conformance.
The CPSC also said Dr Reddy’s violated the Consumer Product Safety Act by not immediately advising it about the violations.
In a US stock exchange filing last week, Dr Reddy’s denied the allegations and said it is engaged in discussions with the CPSC. “An unfavourable outcome in these matters could result in significant liabilities” and “a material adverse effect” on the company, it said.
Separately, the US Department of Justice (DOJ) is also investigating the accusations under the Federal False Claims Act.
The Poison Prevention Packaging Act was enacted in 1970 and requires packaging for hazardous household substances to be “significantly difficult” for children under five years to open “within a reasonable time” but “not difficult for normal adults to use properly.”
Under US law prescription drugs may be dispensed in non-child-resistant packaging at the specific request of the prescribing doctor or the patient.
Child safety is the not the only reason behind pharma companies’ packaging troubles.
In February this year, Pfizer stopped production of its thyroid drug Levoxyl (levothyroxine sodium) because of musty smells traced back to its oxygen-absorbing canister.
Penn Pharma recalled seizure treatment midazolam in June because incorrectly placed screw caps allowed water evaporation, making the remaining product more concentrated.