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Class III: unlikely to cause harmTerminated

VistaPharm Metoclopramide Oral Solution Recall

METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, This cup delivers 10 mL, Rx Only, Manufact…

VistaPharm, Inc. · Largo, FL

Risk level
Class III
Reported by FDA
Sep 5, 2012
Recall ID
D-1669-2012
Check your lot numberHow we source this data

Summary

VistaPharm recalled Metoclopramide Oral Solution starting Jan 19, 2011. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1669-2012 on Sep 5, 2012. Reason: Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," instead of "10 mL x 50,". Status: Terminated.

Why it was recalled

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

Product description

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

Lot numbers, UPCs & expiration codes

195900 exp. 01/12.

Where it was sold

Nationwide

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-1669-2012
Classification
Class III
Status
Terminated
Recall initiated
Jan 19, 2011
FDA report date
Sep 5, 2012
Quantity
73,800 cups
Recall type
Voluntary: Firm initiated
Recalling firm
VistaPharm, Inc.

Original FDA data

Every field from FDA enforcement report D-1669-2012, exactly as published.

Show all FDA fields
City
Largo
State
FL
Status
Terminated
Country
United States
Event ID
62887
Address
7265 Ulmerton Rd
Code information
195900 exp. 01/12.
Postal code
33771-4809
Report date
Sep 5, 2012
Product type
Drugs
Recall number
D-1669-2012
Classification
Class III
Recalling firm
VistaPharm, Inc.
Product quantity
73,800 cups
Termination date
Aug 30, 2012
Reason for recall
Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," instead of "10 mL x 50,"
Voluntary / mandated
Voluntary: Firm initiated
Product description
METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, This cup delivers 10 mL, Rx Only, Manufactured by VistaPharm, Inc., Largo FL33771
Distribution pattern
Nationwide
Recall initiation date
Jan 19, 2011
Initial firm notification
Letter
Center classification date
Aug 29, 2012

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1669-2012, published Sep 5, 2012. 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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