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Novartis recalls Sandimmune and Neoral over risk of poisoning

The company is recalling 100mg blister packages of both Sandimmune and Neoral due to their packaging not being child-resistant, a fault that could result in infants being poisoned.

blister packets of yellow pills

Novartis Pharmaceuticals Corporation is recalling blister packages of Sandimmune® (cyclosporine capsules, USP) 100mg soft gelatin capsules and Neoral® (cyclosporine capsules, USP) MODIFIED 100mg soft gelatin capsules due to the packaging not being child-resistant.

At present, neither the company nor the US Consumer Product Safety Commission have received reports of adverse events due to this fault. However, the packaging is required to be child-resistant by the Poison Prevention Packaging Act (PPPA), because the medicine poses a risk of poisoning if the contents are swallowed by young children.

The company expects 73,000 units to be recalled. The drugs were sold as prescription medicines between March 2018 and 2020. Information about the affected lot numbers is listed below: 

Recalled Prescription Drugs

NDC Numbers

Lot Numbers

Expiration Date

Sandimmune (cyclosporine capsules, USP) 100mg soft gelatin capsules

0078-0241-15

0078-0241-61

APCA136

APCA339

APCA793

APCC238

09/2020

02/2021 or 01/2022

07/2022

Neoral (cyclosporine capsules, USP) MODIFIED 100mg soft gelatin capsules

0078-0248-15

0078-0248-61

APCA437

APCA979

07/2020

03/2021

According to the company, consumers with this medication must secure it out of the reach of children and can contact the firm to request a free child-resistant pouch in which to store the packages until they have finished it or new child-resistant blister packaging is available.

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