Sandoz Recalls Aprepitant Capsules and Lidocaine and Prilocaine Cream Prescription Drugs Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning

Aprepitant capsules and Lidocaine and Prilocaine cream

Date of Recall

2023-03-09

CPSC Release Number

23-146

Manufactured In

Slovenia (Aprepitant Capsules) and United States (Lidocaine and Prilocaine cream)

Units

About 156,750

Manufacturer

Sandoz Inc., of Princeton, New Jersey (Lidocaine and Prilocaine cream)

Importer

Sandoz Inc., of Princeton, New Jersey (Aprepitant Capsules)

Sold By

Pharmacies nationwide as a prescribed medicine from October 2020 through January 2023. The prices of the medications varied based on health insurance terms and other factors.

Problem/Hazard

The recalled prescription drugs and products that contain lidocaine must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.

Injuries/Incidents

None reported

Description

This recall involves prescription drugs Aprepitant 125 mg capsules sold in cartons containing one blister card of 6 capsules and 5 gram tubes of Lidocaine and Prilocaine cream sold in cartons containing 5 tubes and packed with or without 12 dressings. The Aprepitant capsules are in a non-child resistant blister card packaged in a carton that has the name "Sandoz," the name of the medication, dosage, NDC number, lot number, and expiration date on the carton and on the blister cards. The warnings "This unit-dose packaging is not child-resistant" and "For institutional use only" are listed on the carton.

The Lidocaine and Prilocaine cream is packaged in a 5 gram tube with a continuous thread white closure. The name "fougera®," the name of the medication, dosage and NDC number are printed on the carton and tube and the expiration date and lot number are printed on the carton and stamped on the crimp of the tube. The warning "FOR HOSPITAL USE ONLY" is printed on the carton and the tube.

The recall includes the following:

Product Description	NDC Number	Lot Number	Expiration Date
Aprepitant Capsules 125 mg	0781-2323-68 Carton of 1 Blister Pack of 6 capsules 0781-2323-06 Blister Pack	LK3209 LC6454	04/2024 12/2023
Lidocaine and Prilocaine 2.5%/2.5% Cream 5 gram Tubes	0168-0357-56 Carton of 5 tubes and 12 dressings 0168-0357-55 Carton of 5 tubes 0168-0357-05 Tube	LA2782 LA2784 LV0667 LX5350 MA1640 MB3205 LA2785 LR9041 MB3209	03/2023 03/2023 02/2024 03/2024 03/2024 04/2024 03/2023 11/2023 04/2024

Remedy

New Instructions

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