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
Reported: May 11, 2016 Initiated: April 18, 2016 #D-0838-2016
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.
Details
- Recalling Firm
- VistaPharm, Inc.
- Units Affected
- 8,901 cases
- Distribution
- Nationwide
- Location
- Largo, FL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by VistaPharm, Inc.. Units affected: 8,901 cases.
Why was this product recalled? ▼
Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 11, 2016. Severity: Moderate. Recall number: D-0838-2016.
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