Tris Pharma, the manufacturer of multiple generic brands of infant ibuprofen, has recalled specific lots of the drug sold at Walmart, CVS Pharmacy, and Family Dollar.
The formulation of the liquid ibuprofen, which is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain and fever, comes in 0.5ml bottles, with a dosage of 50mg of ibuprofen per 1.25ml.
The infant ibuprofen at issue is indicated for infants between the ages of six (6) months and twenty-three (23) months.
Product Recall Information
Tris Pharma has released the following information regarding the lots or “batches” of infant ibuprofen that are subject to the recent recall:
- Walmart (Equate) – NDC No. 49035-125-23
- Lot No. 00717009A; Expiration February 2019
- Lot No. 00717015A; Expiration April 2019
- Lot No. 00717024A; Expiration August 2019
- CVS Pharmacy/Family Dollar – NDC No. 55319-250-23
- Lot No. 00717024A; Expiration August 2019
Anyone who has purchased infant ibuprofen from Walmart, CVS Pharmacy, or Family Dollar should immediately check the NDC numbers, LOT numbers, and expiration date identified on the packaging of the product. Purchasers are instructed to discard the infant ibuprofen immediately, and retailers are instructed to remove the infant ibuprofen from their shelves.
At this time, no adverse events have been reported. However, many individuals are unaware of what steps to take to report adverse events. As such, many adverse events to drugs and medical devices are never reported to the Food and Drug Administration (FDA). Once purchasers become aware of the recall and understand how to report adverse events to the FDA, it will not be surprising to find out that many infants have suffered the consequences of taking defective infant ibuprofen manufactured by Tris Pharma, as explained below.
Consequences of Taking Defective Infant Ibuprofen
Tris Pharma reports that the side effects, and therefore, the consequences, of taking infant ibuprofen at higher-than-indicated concentrations, include, but may not be limited to, the following:
• Upper abdominal pain;
• Gastrointestinal pain;
• Ringing in the ears;
• Headache; and
• Permanent NSAID-associated renal injury in infants.
Because infants and children are not able to fully communicate their symptoms at such a young age, many parents may not realize that their child is suffering from the side effects of overly-concentrated ibuprofen. As such, parents should act immediately to seek medical attention if their infants or children are complaining of or showing any of the above-listed symptoms. With permanent NSAID-associated renal injury, there is simply no way to determine if a child is suffering from this health condition without a medical diagnosis.
Pursuing Legal Action
Any infant or young child who has suffered side effects from taking recalled infant ibuprofen may have a legitimate product liability lawsuit against the manufacturer of the defective product, especially if the side effects are permanent, such as NSAID-associated renal injury. However, even if injuries are not permanent, parents and guardians are still having to pay hundreds, if not thousands, in medical bills to ensure affected infants and children are receiving necessary medical treatment. Emergency room bills can be catastrophic, and just one day of care can exceed $1,000. Legal action is one way to hold pharmaceutical manufacturers accountable for putting defective drugs on the market and recovering medical expenses that should never have been incurred in the first place.
Contact Parker Waichman LLP Today to Schedule Your Free Consultation
If your infant child has suffered an illness or injury after taking infant ibuprofen, you may have a potential legal claim that you should discuss with a Defective Drug Lawyer. Parker Waichman LLP is a nationally-known law firm that handles a variety of personal injury matters for clients throughout the United States. Our legal team is well-equipped to thoroughly evaluate your potential claim. To schedule a free consultation, contact Parker Waichman LLP today by calling 1-800-YOUR-LAWYER (1-800-968-7529).
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