FDAFDA · Food and drugs·Recall number D-1037-2017
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.
Published August 9, 2017 · Recall initiated: July 5, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Precision Dose Inc.
- Distributor
- OH and CT
- Lot
- Lot #: 500326, Exp. 6/30/2018
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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