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https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abbott-voluntarily-recalls-certain-lots-2-fl-oz5...
Submission: On October 17 via manual from US — Scanned from DE
Submission: On October 17 via manual from US — Scanned from DE
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* Skip to main content * Skip to FDA Search * Skip to in this section menu * Skip to footer links An official website of the United States government Here’s how you know The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site. The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. U.S. FOOD AND DRUG ADMINISTRATION * Search * Menu Search FDA Submit search FEATURED * Contact FDA * FDA Guidance Documents * Recalls, Market Withdrawals and Safety Alerts * Press Announcements * Warning Letters * Advisory Committees * En Español PRODUCTS * Food * Drugs * Medical Devices * Radiation-Emitting Products * Vaccines, Blood, and Biologics * Animal and Veterinary * Cosmetics * Tobacco Products TOPICS * About FDA * Combination Products * Regulatory Information * Safety * Emergency Preparedness * International Programs * News and Events * Training and Continuing Education * Inspections and Compliance * Science and Research INFORMATION FOR * Consumers * Patients * Industry * Health Professionals * Federal, State and Local Officials In this section: Recalls, Market Withdrawals, & Safety Alerts * Recalls, Market Withdrawals, & Safety Alerts * Recall Resources * Enforcement Reports * Industry Guidance For Recalls * Major Product Recalls * Archive for Recalls, Market Withdrawals & Safety Alerts 1. Home 2. Safety 3. Recalls, Market Withdrawals, & Safety Alerts 4. Abbott Voluntarily Recalls Certain Lots of 2 Fl. Oz./59 mL Bottles of Ready-to-Feed Liquid Products; Recall Is Not Expected to Impact U.S. Infant Formula Supply 1. Recalls, Market Withdrawals, & Safety Alerts COMPANY ANNOUNCEMENT ABBOTT VOLUNTARILY RECALLS CERTAIN LOTS OF 2 FL. OZ./59 ML BOTTLES OF READY-TO-FEED LIQUID PRODUCTS; RECALL IS NOT EXPECTED TO IMPACT U.S. INFANT FORMULA SUPPLY When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos * Share * Tweet * Linkedin * Email * Print SUMMARY Company Announcement Date: October 14, 2022 FDA Publish Date: October 14, 2022 Product Type: Food & Beverages Infant Formula & Foods Reason for Announcement: Recall Reason Description Potential for spoilage Company Name: Abbott Brand Name: Brand Name(s) Multiple brand names Product Description: Product Description Ready-to-feed liquid products for infants and children -------------------------------------------------------------------------------- COMPANY ANNOUNCEMENT Abbott is initiating a proactive, voluntary recall of certain lots of 2 fluid ounce/59 milliliter bottles of Ready-to-Feed liquid products for infants and children, including the brands Similac® Pro-Total ComfortTM, Similac® 360 Total Care®, Similac 360 Total Care Sensitive, Similac® Special Care® 24, Similac Stage 1, Similac® NeoSure®, Similac Water (Sterilized) and Pedialyte Electrolyte Solution. The products included in the recall were manufactured at our Columbus, Ohio, manufacturing facility. These products are being recalled because a small percentage of bottles (less than 1%) in the recalled lots have bottle caps that may not have sealed completely, which could result in spoilage. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur. This recall does not include any other liquid or powder formula brands or other nutrition products produced in our Columbus facility or elsewhere within our global nutrition manufacturing network. It also does not include any amino acid-based formulas or metabolic nutrition formulas. This recall equates to less than one day's worth of the total number of ounces of infant formula fed in the U.S. and is not expected to impact the overall U.S. infant formula supply. Abbott is continuing production of Similac 2 fluid ounce/59 milliliter Ready-to-Feed liquid formula products for hospitals and healthcare providers' offices on a different production line. Similac infant formula will continue to be produced in alternative product sizes and formats for delivery to retail locations, in addition to increased production throughout our global manufacturing network. The products included in the recall were distributed primarily to hospitals and to some doctors’ offices, distributors and retailers in the U.S., including Puerto Rico; one lot of products was sent to Barbados, Bermuda, Colombia, the Dominican Republic, Haiti, Jamaica, St. Croix and St. Thomas; and two lots were sent to Canada, Curacao, Panama, and Trinidad and Tobago. WHAT PARENTS AND CAREGIVERS SHOULD DO If a product is included in the recall, do not use the product. For all feeding-related questions or questions about your child’s health, contact a healthcare professional. To identify if your product is included, please visit similacrecall.comExternal Link Disclaimer to view a list of impacted lot numbers or use the lot number checker on the webpage. "We take our responsibility to deliver high-quality products very seriously," said Joe Manning, executive vice president, nutritional products, Abbott. "We internally identified the issue, are addressing it, and will work with our customers to minimize inconvenience and get them the products they need." If you have questions, please contact Abbott's Consumer Relations hotlines below in the country where you received product: * U.S.: +1-800-986-8540 * Puerto Rico: +1-787-622-5454 * Barbados: 246-417-0777 * Bermuda: 279-5568 * Canada: 1-855-733-4201 * Colombia: 1-800-518-9379 * Curacao: 737-2222 Ext. 235, 205 * Dominican Republic: +1-849-200-1564 * Haiti: 868-687-0223 * Jamaica: 876-927-7098 * Panama: 800-0410 * St. Croix: 1(340) 690-7222 * St. Thomas: 1(340) 690-7222 * Trinidad & Tobago: 868-687-0223 -------------------------------------------------------------------------------- COMPANY CONTACT INFORMATION Consumers: Abbott's Consumer Relations 1-800-986-8540 -------------------------------------------------------------------------------- PRODUCT PHOTOS * * CONTENT CURRENT AS OF: 10/14/2022 * REGULATED PRODUCT(S) * Food & Beverages * Infant Formula & Foods * FOLLOW FDA * Follow @US_FDA on TwitterExternal Link Disclaimer * Follow FDA on FacebookExternal Link Disclaimer * Follow @FDArecalls on TwitterExternal Link Disclaimer * Recent Recalled Product Photos on FDA's Flickr PhotostreamExternal Link Disclaimer More Recalls, Market Withdrawals, & Safety Alerts * Recalls, Market Withdrawals, & Safety Alerts * Recall Resources * Enforcement Reports * Industry Guidance For Recalls * Major Product Recalls * Archive for Recalls, Market Withdrawals & Safety Alerts FOOTER LINKS * FDA Archive * About FDA * Accessibility * Visitor Information * Website Policies / Privacy * No FEAR Act * Vulnerability Disclosure Policy * FOIA * HHS.gov * USA.gov Contact FDA Follow FDA on Facebook Follow FDA on Twitter View FDA videos on YouTube Subscribe to FDA RSS feeds FDA Homepage Contact Number 1-888-INFO-FDA (1-888-463-6332) Back to Top