McNeil Consumer Healthcare Announces Voluntary Recall of Motrin® Infants Drops By Tod Aronovitz | 10/03/13 | 0 Comment

Three lots of Concentrated Motrin® Infants’ Drops Original Berry Flavor 1/2 fl oz.—approximately 200,000 bottles—are being voluntarily recalled by McNeil Consumer Healthcare Division due to a potential risk that the product may be contaminated with tiny plastic particles. According to the company, no illnesses or injuries have been reported with the product, which is used to lower fever and treat aches and pains in children 2 years old and younger.

Owned by Johnson & Johnson, McNeil Consumer Healthcare has notified retailers to remove the affected lots from store shelves, and has urged consumers to stop using and dispose of any product.

The three lots of Motrin Infants’ Drops Original Berry Flavor ½ fl oz. (NDC 50580-100-18) included in the recall are:

  • DCB3T01
  • DDB4R01
  • DDB4S01

Bottles can be identified by the UPC code 300450524157, or the case UPC 30300450524158.

The company decided to issue the recall as a precautionary measure. After releasing the Concentrated Motrin Infants’ Drops to the market, tiny plastic particles the size of a poppy seed were found in a different product, not released to the market, during the manufacturing process.  McNeil determined that the particles originated in a shipment from a third party supplier of ibuprofen, the active ingredient in the affected medicine, and recalled the three lots made with the same batch of ibuprofen.  The company is working with the supplier to ensure corrective measures are in place and effective.

Concentrated Infants’ Motrin Drops Dye-Free Berry Flavor 1 fl oz. is not included in this recall. Children’s or Adult Motrin products are also not included in this recall.

Adverse events related to the use of this product may be reported to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting Program:

Consumers who have purchased the product can call the McNeil Consumer Healthcare for a refund at 1-877-414-7709.

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