Reported Nov 17, 2021 · Terminated
Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup
Precision Dose Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Precision Dose Inc. · 722 Progressive Ln · South Beloit, IL · 61080-2616
Is this the product you have?
Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 30-count case (NDC 30-count case: 68094-231-62), and |
| 2 | 100-count case (NDC 100-count case: 68094-231-61), Hospital Use Only, Pkg. Precision Dose, Inc. |
| 3 | Beloit, IL 61080. |
- Lot codes and dates
- Lot#: 503670
- Amount recalled
- 166,920 unit dose cups
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
cGMP Deviations: Product manufactured with contaminated raw ingredient.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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