PhotoTris Pharma is expanding its earlier recall of Ibuprofen Oral Suspension Drops by adding three additional lots.

Some units from these batches have been found to have higher levels of Ibuprofen concentration.

No serious adverse events have been reported to date.

The following six lots of the product, used as a pain reliever/fever reducer and packaged in ½-oz., and 1-oz., bottles, are being recalled:

Lot No.NDCEXPIRATIONDESCRIPTIONCOMPANY
471859779-925-2312/19CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 0.5 oz. bottleCVS Pharmacy
00717005A49035-125-2402/19Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottleWal-Mart Stores Inc.
00717006A59779-925-24

 

(Labeled as: 50428-1252-4)

02/19CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottleCVS Pharmacy
00717009A
(Previously announced)
49035-125-2302/19Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottleWal-Mart Stores Inc
00717015A
(Previously announced)
49035-125-2304/19Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottleWal-Mart Stores Inc
00717024A
(Previously announced)
49035-125-2308/19Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottleWal-Mart Stores Inc
59779-925-23CVS Health: Ibuprofen Oral Suspension Drops,
USP, 50 mg per 1.25 ml, in 0.5 oz. bottle
CVS Pharmacy
55319-250-23Family Wellness: Ibuprofen Oral Suspension Drops,
USP, 50 mg per 1.25 ml, in 0.5 oz. bottle
Family Dollar Services Inc.

What to do

Consumers with questions regarding this recall may contact Tris customer service at (732) 940-0358, Monday through Friday, 8:00 AM – 5:00 PM (PT) or by email at micc_tris@vigilarebp.com.

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