Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (NDC Individual cup: 68094-330-59), in a) 30-count case (NDC 30-count case: 68094-330-62), and b) 100-count case (NDC 100-count case: 68094-330-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080.
Reported: November 17, 2021 Initiated: November 1, 2021 #D-0095-2022
Product Description
Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (NDC Individual cup: 68094-330-59), in a) 30-count case (NDC 30-count case: 68094-330-62), and b) 100-count case (NDC 100-count case: 68094-330-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080.
Reason for Recall
cGMP Deviations: Product manufactured with contaminated raw ingredient.
Details
- Recalling Firm
- Precision Dose Inc.
- Units Affected
- 151,100 unit dose cups
- Distribution
- Nationwide USA
- Location
- South Beloit, IL
Frequently Asked Questions
What product was recalled? ▼
Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (NDC Individual cup: 68094-330-59), in a) 30-count case (NDC 30-count case: 68094-330-62), and b) 100-count case (NDC 100-count case: 68094-330-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080.. Recalled by Precision Dose Inc.. Units affected: 151,100 unit dose cups.
Why was this product recalled? ▼
cGMP Deviations: Product manufactured with contaminated raw ingredient.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 17, 2021. Severity: Moderate. Recall number: D-0095-2022.
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