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Recall Observatory FDA recall evidence

Drug 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

D-0838-2016

April 18, 2016

Class II

Product summary

Firm
VistaPharm, Inc.
Event
Event 73909
Status
Terminated
Classification
Class II
Quantity
8,901 cases
Official record key
drug-enforcement:D-0838-2016

Official wording

Reason: Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage.

Code information: Lot # 435200, EXP 01/18

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage.