Drug recall D-0095-2022
Product
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.
Lots and codes
Lot#: 503679, 503693, 503715
Recall details
- Recalling firm
- Precision Dose Inc., South Beloit, IL
- Quantity
- 151,100 unit dose cups
- Distribution
- Nationwide USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 1, 2021
- Terminated
- July 14, 2024
Related products
- Acetaminophen – drug information
- NDC 68094-231 Acetaminophen · Acetaminophen 160 mg/5mL · Precision Dose, Inc.
- NDC 68094-030 Acetaminophen · Acetaminophen 160 mg/5mL · Precision Dose, Inc.
- NDC 68094-330 Acetaminophen · Acetaminophen 160 mg/5mL · Precision Dose, Inc.