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Recall Observatory FDA recall evidence

Drug product

METOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, 10 mL cups, Rx only. Manufactured by VistaPharm, Inc, Largo, FL. NDC: 66689-031-01.

D-1831-2015

June 26, 2015

Class III

Product summary

Firm
VistaPharm, Inc.
Event
Event 71601
Status
Terminated
Classification
Class III
Quantity
84,100 Cups
Official record key
drug-enforcement:D-1831-2015

Official wording

Reason: Defective Container: Lids on unit dose cups are not fully qualified.

Code information: Lot #: 387500, Expiry: 01/17

Distribution pattern: U.S. Including: CA, IL, LA, OH, PA, and SC.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defective Container: Lids on unit dose cups are not fully qualified.