Novartis, Sandoz Issue Voluntarily Recall Over Child Safety Concerns
July 6, 2018 – Drug manufacturer Novartis and its affiliate Sandoz have recalled nearly half-a-million packages of drugs stored in blister packs after a child opened a pack and ingested haloperidol, an antipsychotic medication. The drug had been distributed in a blister pack meant to be child-proof.
The recall includes a variety of medications stored in the blister packs. The Consumer Product Safety Commission announced that the packs are “not child resistant as required by the Poison Prevention Packaging Act,” and that the drugs stored in these packs pose “a poisoning risk if swallowed by children.” Patients can report an incident and access a full list of affected products at the commission’s website:
In a press release, Novartis and Sandoz instructed patients to call 1-888-NOW NOVA (1-888-669-6682) for instructions if their medication is affected by the recall. According to the companies, there are no quality or safety issues with the recalled medications when used appropriately. Affected blister packs should be stored safely out of reach and sight of children, and patients should continue to take their medications as directed by their prescribers.
Products distributed in bottles are not affected by the recall.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.