Recalls / Class II
Class IID-0335-2019
Product
infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-23, UPC 0 78742 02016 7.
- Affected lot / code info
- Lot #: 00717009A, Exp 02/19; 00717015A, Exp 04/19; 00717024A, Exp 08/19
Why it was recalled
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Recalling firm
- Firm
- Tris Pharma Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2033 US Highway 130, Monmouth Junction, New Jersey 08852-3003
Distribution
- Quantity
- 164,304 bottles
- Distribution pattern
- One distributor in PA who further distributed Nationwide in the USA.
Timeline
- Recall initiated
- 2018-11-26
- FDA classified
- 2018-12-17
- Posted by FDA
- 2018-12-26
- Terminated
- 2021-04-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0335-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.