FDA Recall Infants Pain And Fever
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The most recent Recall Enforcement Report that covers this product was initiated on October 26th, 2021 and classified as a Class II recall due to cgmp deviations: products were manufactured with contaminated excipient that was recalled from the excipient supplier. This recall is currently terminated, and the associated recall number is recall number is D-0595-2022. It pertains to Infants Pain And Fever identified by 30142-766 as of 09-29-2023 .
| Recall Number | Recall Initiation Date | Report Date | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|
| D-0595-2022 | 10-26-2021 | 03-02-2022 | 1,296 bottles | Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC: 30142-766-16 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Terminated |
| D-0596-2022 | 10-26-2021 | 03-02-2022 | 5,184 bottles | Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC: 30142-766-16 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Terminated |
| D-005-2014 | 11-01-2013 | 11-27-2013 | 27,504 bottles | Acetaminophen suspension liquid, 160 mg/5 mL, dye-free grape flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) TopCare Infants' Pain & Fever acetaminophen, Distributed by Topco Associates LLC, Elk Grove Village, IL 60007, NDC 36800-766-16, UPC 0 36800 34650 5; b) Meijer Infants' Pain & Fever acetaminophen oral suspension, Dist. By Meijer Distribution, Inc., 2929 Waler Ave. NW, Grand Rapids, MI 49544, NDC 41250-766-16, UPC 7 13733 31403 9; c) Rite Aid infants' fever reducer & pain reliever oral suspension, Distributed By: Rite Aid, 30 hunter Lane, Camp Hill, PA 17011, UPC 0 11822 35341 0; d) Walgreens infants' Dye-Free Pain & Fever acetaminophen suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0766-16, UPC 3 11917 13223 5; e) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-766-16, UPC 0 41260 35830 2 | Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings. | Terminated |
What is a Recall Enforcement Report?
A Recall Enforcement Report is an official publication by the FDA that documents all classified drug recalls.
When a company initiates a product removal or correction, the FDA evaluates whether the action meets the criteria for a recall. If it does, the FDA assesses the level of public health risk and assigns a recall classification (Class I, II, or III). Once classified, the recall is published in the Enforcement Report, which includes details such as the product name, affected lot numbers, reason for recall, and scope of distribution.
The Enforcement Report ensures transparency and allows the public and healthcare professionals to stay informed about products that may present a health or safety concern.
Understanding Recall Reports
The recall information provided on this website is sourced directly from official U.S. Food and Drug Administration (FDA) data. It is important to understand that most product recalls are limited in scope and typically involve only specific lots or batches of a product that have been identified as potentially defective or non-compliant with regulatory standards.
Recalls may be initiated voluntarily by the manufacturer or distributor, or they may be mandated by the FDA when a product is found to pose a health risk. A recall does not necessarily mean that all units of a product are unsafe.
If you have concerns about the safety of a medication or healthcare product you are using, it is strongly recommended that you verify the product’s lot number and consult your pharmacist or healthcare provider to determine whether your specific product is affected by the recall.
