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Recall Observatory FDA recall evidence

Drug product

METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, (present as the hydrochloride), 10 mL cups, Rx only. Manufactured by VistaPharm Inc., Largo, FL 33771. NDC 66689-031-01.

D-0010-2015

August 13, 2014

Class II

Product summary

Firm
VistaPharm, Inc.
Event
Event 69250
Status
Terminated
Classification
Class II
Quantity
322,650 Cups
Official record key
drug-enforcement:D-0010-2015

Official wording

Reason: Defective Container: Product leaks when inverted.

Code information: Lot #: 283700, Expiry: 11/14; Lot #: 291400, Expiry: 01/15; and Lot #: 303500, Expiry: 04/15.

Distribution pattern: U.S. Nationwide, including Puerto Rico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defective Container: Product leaks when inverted.