Recalls / Class II
Class IID-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.
- Brand name
- Acetaminophen
- Generic name
- Acetaminophen
- Active ingredient
- Acetaminophen
- Route
- Oral
- NDCs
- 68094-030, 68094-231, 68094-330
- FDA application
- M013
- Affected lot / code info
- Lot#: 503679, 503693, 503715
Why it was recalled
cGMP Deviations: Product manufactured with contaminated raw ingredient.
Recalling firm
- Firm
- Precision Dose Inc.
- Manufacturer
- Precision Dose, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 722 Progressive Ln, N/A, South Beloit, Illinois 61080-2616
Distribution
- Quantity
- 151,100 unit dose cups
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2021-11-01
- FDA classified
- 2021-11-05
- Posted by FDA
- 2021-11-17
- Terminated
- 2024-07-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0095-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.