September 6, 2013 – McNeil Consumer Healthcare is voluntarily recalling approximately 200,000 bottles, of Concentrated MOTRIN® Infants’ Drops Original Berry Flavor 1/2 fl oz bottles distributed in the United States.
Product Name: Concentrated Motrin Infants’ Drops
1/2 fl. oz. Berry Flavor (Box can be seen on the right)
Recall Date: September 6, 2013
Reason for Recall:
Tiny plastic particles (approximately 1 mm in size or about the size of a poppy seed) were identified in a different product lot during manufacturing that was not released on to the market. It was determined that the particles originated in a shipment from a third party supplier of ibuprofen, (the active ingredient in Concentrated MOTRIN® Infants’ Drops Original Berry Flavor 1/2 fl oz.) For safety measures, McNeil is voluntarily recalling the three lots released to the market made with the same batch of active ingredient. The potential for adverse medical events related to the reason for this recall is not likely.
| Product | Lot # | UPC Code | Case UPC Code |
| Concentrated MOTRIN® Infants’ Drops Original Berry Flavor 1/2 fl oz bottles NDC 50580-100-18 |
DCB3T01 DDB4R01 DDB4S01 |
300450524157 | 30300450524158 |
The only product involved in this recall is the one seen above.
Before You Throw Out That Bottle!!
Call Motrin Consumer Contact: 1-877-414-7709 and ask about a refund! These products are expensive & this was their error, not yours. Whatever you do please make sure to dispose of the product ASAP. Check out the page they’ve set up for more info that states you CAN get a refund: www.motrin.com/VoluntaryRecall
More Info You May Need
Adverse events that may be related to the use of this product may be reported to U.S. Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting Program.
- Online: www.fda.gov/medwatch/report.htm
- Regular mail: Use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
- Fax: 1-800-FDA-0178. To view the original release: http://www.fda.gov/Safety/Recalls/ucm367550.htm
