FDA 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.

Distribution

Nationwide USA

Key facts

Status

Terminated

Initiation date

2021-11-01

Report date

2021-11-17

Termination date

2024-07-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

South Beloit, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0095-2022