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Class III: unlikely to cause harmTerminated

VistaPharm Metoclopramide Oral Solution Recall

METOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, 10 mL cups, Rx only

VistaPharm, Inc. · Largo, FL

Risk level
Class III
Reported by FDA
Oct 7, 2015
Recall ID
D-1831-2015
Check your lot numberHow we source this data

Summary

VistaPharm recalled Metoclopramide Oral Solution starting Jun 26, 2015. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1831-2015 on Oct 7, 2015. Reason: Defective Container: Lids on unit dose cups are not fully qualified. Status: Terminated.

Why it was recalled

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

Product description

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

Lot numbers, UPCs & expiration codes

Lot #: 387500, Expiry: 01/17

Where it was sold

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

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1831-2015
Classification
Class III
Status
Terminated
Recall initiated
Jun 26, 2015
FDA report date
Oct 7, 2015
Quantity
84,100 Cups
Recall type
Voluntary: Firm initiated
Recalling firm
VistaPharm, Inc.

Original FDA data

Every field from FDA enforcement report D-1831-2015, exactly as published.

Show all FDA fields
City
Largo
State
FL
Status
Terminated
Country
United States
Event ID
71601
Address
7265 Ulmerton Rd
Code information
Lot #: 387500, Expiry: 01/17
Postal code
33771-4809
Report date
Oct 7, 2015
Product type
Drugs
Recall number
D-1831-2015
Classification
Class III
Recalling firm
VistaPharm, Inc.
Product quantity
84,100 Cups
Termination date
Feb 14, 2017
Reason for recall
Defective Container: Lids on unit dose cups are not fully qualified.
Voluntary / mandated
Voluntary: Firm initiated
Product description
METOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, 10 mL cups, Rx only. Manufactured by VistaPharm, Inc, Largo, FL. NDC: 66689-031-01.
Distribution pattern
U.S. Including: CA, IL, LA, OH, PA, and SC.
Recall initiation date
Jun 26, 2015
Initial firm notification
E-Mail
Center classification date
Sep 28, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1831-2015, published Oct 7, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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