Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 68094-650-59), packaged in 30-count cups per shipper case (NDC 68094-650-62), Pkg. By: Precision Dose, Inc., S. Beloit, IL 61080.
Reported: April 24, 2013 Initiated: March 21, 2013 #D-250-2013
Product Description
Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 68094-650-59), packaged in 30-count cups per shipper case (NDC 68094-650-62), Pkg. By: Precision Dose, Inc., S. Beloit, IL 61080.
Reason for Recall
Labeling: Not Elsewhere Classified: This unit dose product is being recalled because the product's name includes the word "Children's" which is misleading since the 650 mg dose of acetaminophen contained within it, is an adult dose.
Details
- Recalling Firm
- Precision Dose Inc.
- Units Affected
- 9,268 cases
- Distribution
- Nationwide and Puerto Rico
- Location
- South Beloit, IL
Frequently Asked Questions
What product was recalled? ▼
Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 68094-650-59), packaged in 30-count cups per shipper case (NDC 68094-650-62), Pkg. By: Precision Dose, Inc., S. Beloit, IL 61080.. Recalled by Precision Dose Inc.. Units affected: 9,268 cases.
Why was this product recalled? ▼
Labeling: Not Elsewhere Classified: This unit dose product is being recalled because the product's name includes the word "Children's" which is misleading since the 650 mg dose of acetaminophen contained within it, is an adult dose.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 24, 2013. Severity: Moderate. Recall number: D-250-2013.
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