UNITED STATES (WHTC-AM/FM) — The New Jersey-based Tris Pharma has issued a nation-wide recall for three lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. And, the JBS Tolleson ground beef recall has expanded after more Salmonella cases.
The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.
There is a remote possibility that some infants would suffer permanent NSAID-associated kidney damage. Symptoms would include nausea, vomiting, epigastric pain, or more rarely, diarrhea. Tinnitus (ringing in the ears), headache, and gastrointestinal bleeding are also possible adverse effects.
In announcing the recall, Tris Pharma, Inc. indicated it had not received any reports of adverse events related to the lots of product that are the subject of this recall. But the company was doing the voluntary recall with the FDA’s approval. The lot numbers are:
NDC
LOT
EXPIRATION
DESCRIPTION
COMPANY
49035-125-23
00717009A
00717015A
00717024A
02/19
04/19
08/19
Equate: Infants’
Ibuprofen
Concentrated Oral
Suspension,
USP (NSAID), 50
mg per 1.25 mL,
0.5 oz. bottle
Wal-Mart
Stores Inc
59779-925-23
00717024A
08/19
CVS Health:
Infants’ Ibuprofen
Concentrated Oral
Suspension,
USP (NSAID), 50
mg per 1.25 mL,
0.5 oz. bottle
CVS
Pharmacy
55319-250-23
00717024A
08/19
Family Wellness:
Infants’ Ibuprofen
Concentrated Oral
Suspension,
USP (NSAID), 50
mg per 1.25 mL,
0.5 oz. bottle
Family Dollar
Services Inc.
Consumers with questions regarding this recall can contact Tris Customer Service at (732) 940-0358 (Monday through Friday, 8:00am ET- 5:00pm PT) or via email at Customer Service Email . Consumers should contact their physician or healthcare providerif they have experienced any problems that may be related to taking or using this drug product.
***
The FDA expanded its October recall of ground beef on Dec. 4, 2018, produced by JBS Tolleson, over Salmonella concerns, adding 5,156,076 pounds of raw beef products, which were produced and packed from July 26, 2018 to Sept. 7, 2018. Federal officials are concerned that some product may be frozen and in consumers’ freezers. These products should be thrown away or returned to the place of purchase.
The most common symptoms of Salmonella-related illnesses are diarrhea, abdominal cramps, and fever within 12 to 72 hours after eating the contaminated product. The illness usually lasts four to seven days. Most people recover without treatment. For some, however, the diarrhea may be so severe that the patient needs to be hospitalized. Older adults, infants, and persons with weakened immune systems are more likely to develop a severe illness. Individuals concerned about an illness should contact their health care provider.
While no cases have yet been reported in Michigan, Ohio, Indiana and Illinois have each recorded a single case, so far.
