Precision Dose Recalls Children's Acetaminophen Due to Misleading Labeling
Precision Dose Inc. is recalling Children's Acetaminophen Oral Suspension because the label is misleading. The product contains an adult dose of acetaminophen despite the name.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a moderate severity score. The hazard is a labeling error that could lead to incorrect dosing, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Precision Dose Inc. is recalling Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cups. The recall involves 9,268 cases of the product, which was distributed nationwide and in Puerto Rico.
The recall was initiated because the product's name includes the word "Children's," which is misleading. The 650 mg dose of acetaminophen contained in the unit dose cups is an adult dose, not a pediatric dose. This labeling error could lead to confusion regarding the appropriate dosage for children.
Consumers who have this product should stop using it and contact Precision Dose Inc. or their healthcare provider for instructions on how to proceed. The affected lots have expiration dates ranging from May 2013 to March 2014.
The recalled product
- Product
- 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.
- Manufacturer
- Precision Dose Inc.
- Category
- Drug — Oral Suspension
- Hazard
- Affected units
- 9,268
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- Lot #: 101456
- Exp 05/13
- 101488
- Exp 06/13: 101499
- 101503
- Exp 07/13
- 101537
- 101552
- 101554
- Exp 08/13
- 101611
- 101616
- 101623
- Exp 10/13
- 101630
- Exp 11/13
- 101754
- Exp 03/14
Distribution
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