Recalls / Class II
Class IID-0838-2016
Product
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
- Affected lot / code info
- Lot # 435200, EXP 01/18
Why it was recalled
Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage.
Recalling firm
- Firm
- VistaPharm, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 7265 Ulmerton Rd, Largo, Florida 33771-4809
Distribution
- Quantity
- 8,901 cases
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-04-18
- FDA classified
- 2016-05-04
- Posted by FDA
- 2016-05-11
- Terminated
- 2018-08-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0838-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.