Walmart, CVS & Family Dollar Ibuprofen Recall Expands


US FlagUS/Silver Spring: WalMart, CVS & Family Dollar Children's Ibuprofen Recall [US]Tris Pharma, Inc., a Monmouth Junction, New Jersey establishment, expands its existing recall for certain batch/lots of Walmart, CVS and Family Dollar branded Infants’ Ibuprofen Concentrated Oral Suspension to include additional batch/lots of CVS and Walmart medication. The original recall notification was due to suspected higher than stated doses of Ibuprofen and consequential risk of overdose, severe illness and/or possible life-changing complications, all serious health and safety hazards.

FDA: http://ht.ly/55I430nxfrj

Direct link: https://www.fda.gov/Safety/Recalls/ucm630112.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following children’s liquid pain relief drugs are subject to this recall (in alphabetical order):

  • CVS Pharmacy CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), sold in 50 mg per 1.25 mL, 0.5 ounce bottles with an NDC designation of 59779-925-23 and a batch/lot of 4718 with an expiration date of 12/19
  • CVS Pharmacy CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), sold in 50 mg per 1.25 mL, 0.5 ounce bottles with an NDC designation of 59779-925-24 but labeled as 50428-1252-4 and a batch/lot of 00717006A with an expiration date of 02/19
  • Walmart Stores Inc. Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), sold in 50 mg per 1.25 mL, 0.5 ounce bottles with an NDC designation of 49035-125-24 and a batch/lot of 00717005A with an expiration date of 12/19

The following drug products were recalled by an earlier notification:

  • CVS Pharmacy CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), sold in 50 mg per 1.25 mL, 0.5 ounce bottles with an NDC designation of 59779-925-23 and a batch/lot of 00717024A with an expiration date of 08/19
  • Family Dollar Services Inc. Family Wellness: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), sold in 50 mg per 1.25 mL, 0.5 ounce bottles with an NDC designation of 55319-250-23 and a batch/lot of 00717024A with an expiration date of 08/19
  • Walmart Stores Inc. Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), sold in 50 mg per 1.25 mL, 0.5 ounce bottles with an NDC designation of 49035-125-23 and a batch/lot of 00717009A with an expiration date of 02/19, a batch/lot of 00717015A with an expiration date of 04/19 or a batch/lot of 00717024A with an expiration date of 08/19

Please consult the photograph above for details of the drug’s packaging, design and retail presentation. Additional images of the recalled children’s liquid pain relief drugs can be found on the Web site above.

According to the FDA, the recalled lots of children’s liquid pain relief drugs have been found to potentially have higher concentrations of Ibuprofen. This defect can pose overdose hazards.

Infants who may be more susceptible to a higher potency level of Ibuprofen may be more vulnerable to permanent NSAID-associated Renal Injury. Adverse effects that may be experienced are nausea, vomiting, epigastric pain, or more rarely, diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects. Please seek medical attention if your child exhibits any of these signs.

==> Never depend on your senses of sight, smell, taste or touch to confirm drug poisoning, adulteration or contamination. If in doubt about the safety of any drug, return it to your retailer for refund, making sure neither small children nor household pets can access the suspect medication.

If you believe you have purchased or have in your possession any of the recalled Ibuprofen products, please do not consume them directly nor use them as an ingredient in another preparation. Instead, return the drug to the store where you purchased it for a full refund.

Parents and other caregivers with questions should consult with pharmacists at their respective retailers. Physicians and other healthcare professionals should contact Tris Pharma at 1-732-940-2800 during normal business hours, Eastern Standard Time, Monday to Friday for more information. You can also reach the company using other information supplied on its corporate Contact page: http://www.trispharma.com/contact.

==> To see other recalls and notifications caused by suspected inaccurate dosage hazard, please search for “dosage” using the Search Box at the top of this page.

==> To see other recalls and notifications relating to Children or Infants, please search for “child” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by Tris Pharma, Inc, please search for “Tris Pharma” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold under the CVS Health brand name, please search for “CVS” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold under the Family Wellness brand name, please search for “Family Dollar” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold under the Equate brand name, please search for “Walmart” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 11073-2019
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
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General information:
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Visit the Living Safely site:
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