FDA-Drug2017-08-09Class II
Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080, NDC 68094-301-59.
Precision Dose Inc.
Hazard
Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.
Sold states
OH and CT
Affected count
480 (5mL) unit dose cups
Manufactured in
722 Progressive Ln, N/A, South Beloit, IL, United States
Products
Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080, NDC 68094-301-59.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1037-2017Don't want to check this manually?
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