Novartis and its generics unit Sandoz are voluntarily recalling nearly half a million packages of medications after a child opened a “child-proof” blister pack and ingested a tablet of antipsychotic medication haloperidol.
The recall of 470,000 packages of a variety of drugs was announced Friday by the Consumer Product Safety Commission, which said, “The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act, posing a poisoning risk if swallowed by children.”
It didn't say how, or if, the child was affected.
In a statement, Novartis said it contacted the CPSC and FDA as soon as it learned of the issue.
“At Sandoz and Novartis, we take our responsibility for consumer safety very seriously.”
It pointed out that there is no question about the quality of the drugs, only about the child deterrence of the packaging, and that patients should continue to take their drugs.
Novartis recalled Zofran, which controls nausea in cancer patients, and heart drug Entresto. Sandoz recalled the haloperidol, along with eight other drugs:
- infection fighter azithromycin.
- Alzheimer’s drugs donepezil and imipramine.
- isosorbide dinitrate; naratriptan.
- ondansetron and ondansetron ODT.
Regulators take this kind of packaging problem very seriously. In December of last year, Dr. Reddy’s Laboratories paid $5 million to settle a long-running Justice Department probe into claims that it purposely distributed prescription drugs in the U.S. with packaging that wasn’t tested for child safety.
In its suit against Dr. Reddy’s, the DOJ alleged that in 2011, the company’s engineers knew that packaging for four drugs it manufactured wouldn’t meet child resistance requirements. The company then began to discreetly alter the packaging and sell the products with untested packaging, the suit claimed.
In 2015, a packaging problem led Merck & Co. to voluntarily retrieve 276,000 bottles of a cancer drug because the child-proof feature could fail, allowing children to get their hands on the chemo drug. In that case, the Consumer Product Safety Commission said bottles of Merck's Temodar and generic temozolomide capsules had caps that could crack, disabling the child-proof closure.