Aprepitant capsules and Lidocaine and Prilocaine cream
CPSC Recall #23-146 — March 9, 2023
Recall Summary
| Recall Number | 23-146 |
| Recall Date | March 9, 2023 |
| Remedy Type | New Instructions, Repair |
| Units Affected | About 156,750 |
| Manufacturer | Sandoz Inc., of Princeton, New Jersey (Lidocaine and Prilocaine cream) |
| Importer | Sandoz Inc., of Princeton, New Jersey (Aprepitant Capsules) |
| Manufactured In | Slovenia (Aprepitant Capsules) and United States (Lidocaine and Prilocaine cream) |
Where It Was Sold
| 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. |
Product
Aprepitant capsules and Lidocaine and Prilocaine cream
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
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.
Incidents & Injuries
None reported
Remedy Instructions
Consumers should immediately secure the medications out of the sight and reach of children and contact Sandoz for a free child resistant pouch to store the products. Once the medication is secured, consumers can continue to use the medication as directed.
What Should You Do?
Stop using this product immediately. Contact the manufacturer for a New Instructions, Repair at no charge. If you experienced an injury, report it at SaferProducts.gov.
Frequently Asked Questions
Follow the consumer action instructions in the recall notice above. Most recalls require you to stop using the product and contact the manufacturer directly — either by calling the toll-free number listed in the official CPSC notice or by visiting the manufacturer's website. You generally do not need a receipt or original packaging to claim a remedy. The manufacturer is legally required to provide the remedy (New Instructions, Repair) at no cost to you.
Yes. If you were injured by a defective consumer product — whether recalled or not — you may have grounds for a product liability claim against the manufacturer and potentially the retailer. A recall notice can serve as evidence that the manufacturer was aware of the defect. Injuries that may support a claim include burns, lacerations, fractures, electric shock, choking incidents, and chemical exposure. Most product liability attorneys work on a contingency fee basis, meaning you pay nothing unless you win. Consult an attorney promptly, as statutes of limitation vary by state.
In most cases, no. CPSC-coordinated recall remedies are designed to be accessible without proof of purchase. Manufacturers typically ask consumers to self-certify ownership and may ask for photos of the product or its serial number. Some manufacturers request that you mail in a portion of the product (such as a cut cord or removed component) as proof of disposal. Check the specific remedy instructions for this recall for exact requirements. If you registered your product at the time of purchase, the process is usually even simpler.
If the original manufacturer has gone out of business, the recall remedy may no longer be available through them. In this case, contact CPSC directly at 1-800-638-2772 or cpsc.gov for guidance. If the brand was acquired by another company, the acquiring company may have assumed recall obligations. In some cases where a remedy is unavailable, CPSC advises consumers to safely dispose of the product. If you were injured by the product of a defunct company, consult a product liability attorney — parent companies, distributors, and retailers may still bear liability in some circumstances.