D-0057-2018 Class III Terminated
FDA drug recall D-0057-2018 was initiated by Precision Dose Inc. on Sep 25, 2017 and is designated Class III. Reason for recall: Subpotent Drug: low out of specification results. The recall status is terminated (terminated Apr 23, 2018). Affected quantity: 801 cases.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 8, 2017
- Initiation Date
- Sep 25, 2017
- Termination Date
- Apr 23, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 801 cases
Product Description
Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per tray, 3 trays per case containing a total of 5 mL x 30 Unit Dose Cups per case (NDC 68094-301-62), Rx only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080.
Reason for Recall
Subpotent Drug: low out of specification results.
Distribution Pattern
Nationwide in the USA
Code Information
Lot number: 500105, Exp 04/30/18
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0057-2018
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026