Sandoz Recalls Aprepitant Capsules and Lidocaine and Prilocaine Cream Prescription Drugs Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning
USSandoz Recalls Aprepitant Capsules and Lidocaine and Prilocaine Cream Prescription Drugs Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning
Recalling Firm: Sandoz Inc., of Princeton, New Jersey (Lidocaine and Prilocaine cream)
Motivo del Retiro / Peligro
TranslatedThe 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.
Descripción del Producto e Identificación
TranslatedThis 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. 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
Productos Afectados
TranslatedAprepitant capsules and Lidocaine and Prilocaine cream
Additional Source Details
| Field | Value |
|---|---|
| U R L | https://www.cpsc.gov/Recalls/2023/Sandoz-Recalls-Aprepitant-Capsules-and-Lidocaine-and-Prilocaine-Cream-Prescription-Drugs-Due-to-Failure-to-Meet-Child-Resistant-Packaging-Requirement-Risk-of-Poisoning |
| Title | Sandoz Recalls Aprepitant Capsules and Lidocaine and Prilocaine Cream Prescription Drugs Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning |
| Images › 1 › U R L | https://www.cpsc.gov/s3fs-public/RecalledAprepitantCapsules125mgNDC_0781_2323_68_Carton.jpg |
| Images › 1 › Caption | Recalled Aprepitant Capsules 125 mg – NDC 0781-2323-68 – Carton |
| Images › 2 › U R L | https://www.cpsc.gov/s3fs-public/RecalledAprepitantCapsules25mgNDC0781232306Blister.jpg |
| Images › 2 › Caption | Recalled Aprepitant Capsules 125 mg – NDC 0781-2323-06 – Bliste |
| Images › 3 › U R L | https://www.cpsc.gov/s3fs-public/RecalledLidocaineandPrilocaineCream5gramtubeNDC0168035705.jpg |
| Images › 3 › Caption | Recalled Lidocaine and Prilocaine Cream - 5 gram tube - NDC 0168-0357-05 |
| Images › 4 › U R L | https://www.cpsc.gov/s3fs-public/RecalledLidocaineandPrilocaineCreamCartonof55gramtubesNDC0168035755.jpg |
| Images › 4 › Caption | Recalled Lidocaine and Prilocaine Cream - Carton of 5 – 5 gram tubes - NDC 0168-0357-55 |
| Images › 5 › U R L | https://www.cpsc.gov/s3fs-public/RecalledLidocaineandPrilocaineCreamCartonof5_5gramtubeswith12dressingsNDC0168035756.jpg |
| Images › 5 › Caption | Recalled Lidocaine and Prilocaine Cream - Carton of 5 – 5 gram tubes with 12 dressings - NDC 0168-0357-56 |
| Hazards › Name | 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 › Name | None reported |
| Products › Name | Aprepitant capsules and Lidocaine and Prilocaine cream |
| Products › Number Of Units | About 156,750 |
| Recall I D | 9556 |
| Remedies › Name | 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. |
| Importers › Name | Sandoz Inc., of Princeton, New Jersey (Aprepitant Capsules) |
| Retailers › Name | 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. |
| Recall Date | 2023-03-09T00:00:00 |
| 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. 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 |
| Recall Number | 23146 |
| Manufacturers › Name | Sandoz Inc., of Princeton, New Jersey (Lidocaine and Prilocaine cream) |
| Remedy Options › 1 › Option | New Instructions |
| Remedy Options › 2 › Option | Repair |
| Consumer Contact | Sandoz toll-free at 866-300-2207 from 8 a.m. to 5 p.m. ET Monday through Friday, email at Sandoz6768@sedgwick.com or online at https://www.us.sandoz.com/patients-customers/product-safety-notices or www.us.sandoz.com and click on "Product Safety Notices" below the carousel for more information. |
| Last Publish Date | 2023-03-09T00:00:00 |
| Manufacturer Countries › 1 › Country | Slovenia (Aprepitant Capsules) |
| Manufacturer Countries › 2 › Country | United States (Lidocaine and Prilocaine cream) |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsCheck the model number, serial number, and date stamp on the rating label on the back or underside of the product.
Immediately discontinue using the product. Unplug electrical items and keep juvenile items out of reach of children.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (CPSC).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Sandoz Recalls Aprepitant Capsules and Lidocaine and Prilocaine Cream Prescription Drugs Due to Failure to Meet Child...?
Immediately stop using the product and keep it out of reach of children. Disconnect power if electrical, and do not attempt makeshift home repairs.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (CPSC). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Resumen
- Empresa ResponsableSandoz Inc., of Princeton, New Jersey (Lidocaine and Prilocaine cream)
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🚨 SAFETY ALERT: Sandoz Inc., of Princeton, New Jersey (Lidocaine and Prilocaine cream) - Sandoz Recalls Aprepitant Capsules and Lidocaine and Prilocaine Cream Prescription Drugs Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning Check if your household is affected: https://therecallfile.com/es/recalls/sandoz-recalls-aprepitant-capsules-and-lidocaine-and-prilocaine-cream/CPSC-23146
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