D-0838-2016 Class II Terminated
FDA drug recall D-0838-2016 was initiated by VistaPharm, Inc. on Apr 18, 2016 and is designated Class II. Reason for recall: Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage. The recall status is terminated (terminated Aug 3, 2018). Affected quantity: 8,901 cases.
Recall Details
- Product Type
- Drugs
- Report Date
- May 11, 2016
- Initiation Date
- Apr 18, 2016
- Termination Date
- Aug 3, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,901 cases
Product Description
Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/ml) (NDC 66689-401-01), shrink- wrapped in 10 unit dose cups x 5 trays per case (NDC 66689-401-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771
Reason for Recall
Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage.
Distribution Pattern
Nationwide
Code Information
Lot # 435200, EXP 01/18
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0838-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026