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.)
Reported: April 1, 2020 Initiated: March 16, 2020 #D-1067-2020
Product Description
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.)
Reason for Recall
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Details
- Recalling Firm
- Glaxosmithkline Consumer Healthcare Holdings
- Units Affected
- 151,056 bottles
- Distribution
- Product was distributed throughout the United States, including Puerto Rico.
- Location
- Warren, NJ
Frequently Asked Questions
What product was recalled? ▼
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.). Recalled by Glaxosmithkline Consumer Healthcare Holdings. Units affected: 151,056 bottles.
Why was this product recalled? ▼
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 1, 2020. Severity: Moderate. Recall number: D-1067-2020.
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