JACKSONVILLE, Fla. — The Duval County Medical Society (DCMS) said Tuesday it was notified about discoloration and particles found in certain Abbott two-ounce bottles of ready-to-feed products, including formula, water and Pedialyte.
The notification arises from concerns reported by multiple local health systems and retailers in Jacksonville, according to a news release from DCMS.
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DCMS said it has not been made aware of any adverse reactions related to these products.
Local health systems are currently assessing their inventories to check for the affected products. Here are the products identified for testing:
| Serial number | Product name |
|---|---|
| 68136 | Similac Pro-Advance 2oz RTF |
| 51000 | Similac Sterile Water 2oz |
| 56177 | Similac Neosure 2oz RTF |
| 56271 | Similac Special Care High Protein 24 cal 2oz RTF |
| 59738 | Similac Alimentum 2oz RTF |
| 68155 | Similac Pro-Sensitive 2 oz RTF |
| 67132 | Similac Pro-Total Comfort 2oz RTF |
| 67389 | Similac Spit-Up 2oz RTF |
| 56267 | Similac Special Care 24 - 2oz RTF |
| 56275 | Similac Special Care 30 cal 2oz RTF |
| 67391 | Similac Soy Isomil 2oz RTF |
| 55251 | Elecare Infant |
| 59892 | Pedialyte Unflavored 2 oz Bottles |
The DCMS said it has confirmed that at least one health system has already reported its concerns to the U.S. Food and Drug Administration (FDA).
DCMS said Abbott has acknowledged the issue and escalated it to their national testing and quality division for further evaluation.
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In the meantime, DCMS said health systems are sourcing similar products from alternative manufacturers to ensure continuous care.
Safety remains a top priority, DCMS said, and individuals concerned about these products are encouraged to reach out to their health care providers for advice.
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On Thursday, DCMS said it received a letter from Todd Reese, Director, Quality Assurance, Nutritional Products, which said the following:
“At Abbott, producing high-quality and safe nutrition products is our highest priority. As a follow-up to our discussion, we want to reassure you, your clinicians and patients that our ready-to-feed liquid infant products are commercially sterile and safe to use.
Our medical and quality teams are assessing the complaints you have shared with us. Analysis of the complaint samples received to date has shown no impact to the product seal or product sterility.
Our medical team has assessed that any product contact with the spots on the lid does not pose a health risk to infants. As we receive and analyze additional samples, we will notify you if our assessment changes. Our manufacturing teams are working diligently to identify the root cause of this spotting and implement appropriate corrective actions.
We appreciate your support and collaboration in this matter, and we will continue to share relevant updates as our investigation progresses."
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