Acetaminophen Oral Suspension Recalled Due to Contaminated Raw Ingredient
Precision Dose Inc. is recalling 166,920 unit dose cups of Acetaminophen Oral Suspension 160 mg/5 mL (Lot 503670) distributed nationwide due to cGMP deviations involving contaminated raw ingredient used in manufacturing.
What this means for you
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: This is an FDA Class II recall. The source text does not report any illnesses, injuries, or confirmed harm from the contaminated raw ingredient—only the potential cGMP deviation. Per the rubric, Class II recalls without reported hospitalization fall into the Moderate category.
Plain-English summary
Precision Dose Inc. is recalling Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL unit dose cups. The product was distributed nationwide in 30-count and 100-count cases for hospital use only. The recall affects 166,920 unit dose cups from Lot 503670.
The recall was issued because the product was manufactured with a contaminated raw ingredient, which constitutes a cGMP (Current Good Manufacturing Practice) deviation.
Consumers and healthcare facilities should stop using this product. Consumers should contact Precision Dose Inc. or consult their healthcare provider if they have questions about whether they have the recalled product or if they have taken it.
The recalled product
- Product
- ACETAMINOPHEN (ACETAMINOPHEN)
- Brand
- ACETAMINOPHEN
- Manufacturer
- Precision Dose Inc.
- Category
- Drug — Oral Suspension
- Affected units
- 166,920
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 (1)
- Lot#: 503670
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Precision Dose Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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