Recalls / Class II
Class IID-0010-2015
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.
- Affected lot / code info
- Lot #: 283700, Expiry: 11/14; Lot #: 291400, Expiry: 01/15; and Lot #: 303500, Expiry: 04/15.
Why it was recalled
Defective Container: Product leaks when inverted.
Recalling firm
- Firm
- VistaPharm, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7265 Ulmerton Rd, Largo, Florida 33771-4809
Distribution
- Quantity
- 322,650 Cups
- Distribution pattern
- U.S. Nationwide, including Puerto Rico
Timeline
- Recall initiated
- 2014-08-13
- FDA classified
- 2014-10-09
- Posted by FDA
- 2014-10-15
- Terminated
- 2015-02-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0010-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.