Drug Recall : KinderFarms OTC Acetaminophen Suspension
StayWell Insurance | November 18, 2023 | Maite, GU
Dear Prescriber:
KinderFarms, LLC is voluntarily recalling all lots of KinderMed Infants’ Pain & Fever (oral suspension) and KinderMed Kids’ Pain & Fever (oral suspension) to the retail and consumer level. These products are being voluntarily recalled due to acetaminophen instability. Ongoing testing of sample batches indicated some product lots were no longer in specification and may pose a health risk. Out of an abundance of caution, KinderFarms has made the decision to voluntarily recall all KinderMed Pain & Fever products.
Acetaminophen is the active ingredient in many pain-relieving medicines. As a result of the potential health risk with acetaminophen being outside of specification, the product may cause acute adverse health effects, including abdominal pain, nausea, vomiting or jaundice at higher doses. The company has not received any reports of serious adverse events from either of these products to date. No other KinderFarms products are impacted by this recall.
The impacted product being voluntarily recalled is all lots of:
| Product | NDC # |
|---|---|
| KinderMed Infants’ Pain & Fever (2 fluid ounces/59 mL), (Acetaminophen - 160 mg per 5 mL), Oral Suspension | 50001080569 |
| KinderMed Kids’ Pain & Fever (4 fluid ounces/118 mL), (Acetaminophen - 160 mg per 5 mL), Oral Suspension | 50001080572 |
This voluntary recall encompasses all product currently available on shelf of these two NDCs only. These products are available nationwide in drug/pharmacy, supermarkets, direct delivery and national retailers, and online through major ecommerce sites.
Consumers who purchased either of these two products should stop using them and may return the product to the place of purchase for a full refund.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax:
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Complete and submit the report Online: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
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Regular Mail or Fax: Download form https://www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
For more information, please review the following press release: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts