Tris Pharma has expanded its voluntary recall of infants' ibuprofen oral suspension drops.
The recall over concerns that the concentration of ibuprofen in some of the lots is too high, as much as 10 percent above the specified limit.
The affected brands include CVS Health and Equate, which is sold at Walmart. Six lots are affected:
New
- CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 0.5 oz. bottle - Lot 4718, NDC 59779-925-23, expiration 12/19;
- Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottle, Lot 00717005A, NDC 49035-125-24, expiration 2/19 and
- CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottle, Lot 00717006A, NDC 59779-925-24 (labeled as: 50428-1252-4), expiration 02/19.
Previously announced
- Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle, Lot 00717009A,NDC 49035-125-23, expiration 2/19
- Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle, Lot 00717015A, NDC 49035-125-23, expiration 04/19
- Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle, CVS Health: Ibuprofen Oral Suspension Drops,USP, 50 mg per 1.25 ml, in 0.5 oz. bottle and Family Wellness: Ibuprofen Oral Suspension Drops,USP, 50 mg per 1.25 ml, in 0.5 oz. bottle, Lot 00717024A, NDCs 49035-125-23, 59779-925-23, 55319-250-23, expiration 08/19.
Consumers with questions regarding this recall may contact Tris Customer Service by 732-940-0358 (Monday through Friday, 8:00 AM ET- 5:00 PM PT) or via email at micc_tris@vigilarebp.com .
They can also contact their healthcare providers if they have experienced problems with this medication.
For more information, visit fda.gov.
(Photo: Getty Images)