Precision Dose Inc.: Drug Recall
Recall #D-0095-2022 · 11/01/2021
Class II: Risk
Recall Details
- Recall Number
- D-0095-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Precision Dose Inc.
- Status
- Terminated
- Date Initiated
- 11/01/2021
- Location
- South Beloit, IL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 151,100 unit dose cups
Reason for Recall
cGMP Deviations: Product manufactured with contaminated raw ingredient.
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.
Distribution Pattern
Nationwide USA
Other Recalls by Precision Dose Inc.
- Class II: Risk 11/01/2021
- Class II: Risk 01/01/2021
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.