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.
Reported: August 9, 2017 Initiated: July 5, 2017 #D-1037-2017
Product Description
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.
Reason for Recall
Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.
Details
- Recalling Firm
- Precision Dose Inc.
- Units Affected
- 480 (5mL) unit dose cups
- Distribution
- OH and CT
- Location
- South Beloit, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Precision Dose Inc.. Units affected: 480 (5mL) unit dose cups.
Why was this product recalled? ▼
Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 9, 2017. Severity: Moderate. Recall number: D-1037-2017.
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