The Recall Desk
ModerateFDA (Drugs)·D-0010-2015·Announced 2014-10-15

VistaPharm Recalls Metoclopramide Oral Solution Due to Leaking Containers

VistaPharm is recalling 322,650 cups of Metoclopramide Oral Solution because the containers leak when inverted.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a packaging defect (leaking) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

VistaPharm, Inc. is recalling 322,650 cups of Metoclopramide Oral Solution, USP 5 mg/5 mL (present as the hydrochloride), 10 mL cups. The product is prescription-only and was distributed nationwide in the U.S., including Puerto Rico.

The recall was initiated because the defective containers leak when inverted. The affected lots are 283700 (expiry 11/14), 291400 (expiry 01/15), and 303500 (expiry 04/15).

Consumers should stop using the product and contact their healthcare provider or pharmacist for instructions on how to dispose of or return the medication.

The recalled product

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.
Manufacturer
VistaPharm, Inc.
Category
Drug — Oral Solution
Hazard
Affected units
322,650

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Lot #: 283700
  • Expiry: 11/14
  • Lot #: 291400
  • Expiry: 01/15
  • and Lot #: 303500
  • Expiry: 04/15.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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