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Recall Observatory FDA recall evidence

Drug product

METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, This cup delivers 10 mL, Rx Only, Manufactured by VistaPharm, Inc., Largo FL33771

D-1669-2012

January 19, 2011

Class III

Product summary

Firm
VistaPharm, Inc.
Event
Event 62887
Status
Terminated
Classification
Class III
Quantity
73,800 cups
Official record key
drug-enforcement:D-1669-2012

Official wording

Reason: Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," instead of "10 mL x 50,"

Code information: 195900 exp. 01/12.

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," instead of "10 mL x 50,"