FDA Drug Recalls

Recalls / Class III

Class IIID-1669-2012

Product

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

Affected lot / code info
195900 exp. 01/12.

Why it was recalled

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

Recalling firm

Firm
VistaPharm, Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
7265 Ulmerton Rd, N/A, Largo, Florida 33771-4809

Distribution

Quantity
73,800 cups
Distribution pattern
Nationwide

Timeline

Recall initiated
2011-01-19
FDA classified
2012-08-29
Posted by FDA
2012-09-05
Terminated
2012-08-30
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1669-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.