Recalls / Class II
Class IID-0495-2019
Product
Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39961 3, NDC 50428-1252-4.
- Affected lot / code info
- Lot#: 00717006A, Exp 02/19
Why it was recalled
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Recalling firm
- Firm
- Tris Pharma Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2033 US Highway 130, N/A, Monmouth Junction, New Jersey 08852-3003
Distribution
- Quantity
- 35,280 bottles
- Distribution pattern
- One distributor who further distributed Nationwide in the USA.
Timeline
- Recall initiated
- 2019-01-15
- FDA classified
- 2019-02-14
- Posted by FDA
- 2019-02-20
- Terminated
- 2023-03-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0495-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.