Drug Safety Alerts

Pediatric Standard 1.2 Vanilla Consumer-Level Recall

8/3/2022

On August 3, 2022, Lyons Magnus issued a consumer-level recall of Pediatric Standard 1.2 Vanilla NDC #51823-0006-90. This recall was issued due to the potential for microbial contamination including the organism Cronobacter sakazakii.

This may represent a potential health hazard or safety risk to patients who may be using product affected by this recall.

This recall affects lot codes 6512 exp. 6/5/2023, 5512 exp. 6/4/2023, 4512 exp. 6/3/2023, 3512 exp. 6/2/2023, and 2512 exp. 6/1/2023.

According to Lyons, while infection related to Cronobacter sakazakii is rare, the common symptoms of illness could include fever, vomiting and urinary tract infection. However, vulnerable and immunocompromised populations may be more susceptible to infection.

Lyons is directing those who have recalled product to immediately return or destroy it.

CVS Caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy contacting patients and prescribers to advise them of this recall.

For more information about this recall, please contact Kate Farms toll-free at 805-845-2446. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.