Recalls / Class II
Class IID-1067-2020
Product
Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz. and 1 oz. bottles NDC 0573-0191-75 (0.75 oz.) NDC 0573-0191-50 (1 oz.)
- Brand name
- Infants Advil
- Generic name
- Ibuprofen
- Active ingredient
- Ibuprofen
- Route
- Oral
- NDC
- 0573-0191
- FDA application
- NDA020812
- Affected lot / code info
- Batch/Lot # R73761, exp. date 01/31/2021, Item # F00573019175, 0.75 oz. R74936, exp. date 02/28/2021, Item # F00573019175, 0.75 oz. R56290, exp. date 03/31/2020, Item # F00573019150, 1 oz. R60959, exp. date 02/28/2021, Item # F00573019150, 1 oz. R78826, exp. date 11/30/2021, Item # F00573019150, 1 oz. 9335UA, exp. date 01/31/2021, item # F00573019175A - Co-package 9336UA, exp. date 02/28/2021, item # F00573019175A - Co-package
Why it was recalled
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Recalling firm
- Firm
- Glaxosmithkline Consumer Healthcare Holdings
- Manufacturer
- Haleon US Holdings LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 184 Liberty Corner Rd, N/A, Warren, New Jersey 07059-6796
Distribution
- Quantity
- 151,056 bottles
- Distribution pattern
- Product was distributed throughout the United States, including Puerto Rico.
Timeline
- Recall initiated
- 2020-03-16
- FDA classified
- 2020-03-26
- Posted by FDA
- 2020-04-01
- Terminated
- 2021-10-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1067-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.