D-1037-2017 Class II Terminated
FDA drug recall D-1037-2017 was initiated by Precision Dose Inc. on Jul 5, 2017 and is designated Class II. Reason for recall: Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC. The recall status is terminated (terminated Mar 28, 2018). Affected quantity: 480 (5mL) unit dose cups.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 9, 2017
- Initiation Date
- Jul 5, 2017
- Termination Date
- Mar 28, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 480 (5mL) unit dose cups
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.
Distribution Pattern
OH and CT
Code Information
Lot #: 500326, Exp. 6/30/2018
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1037-2017
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026