Recalls / Class III
Class IIID-1831-2015
Product
METOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, 10 mL cups, Rx only. Manufactured by VistaPharm, Inc, Largo, FL. NDC: 66689-031-01.
- Affected lot / code info
- Lot #: 387500, Expiry: 01/17
Why it was recalled
Defective Container: Lids on unit dose cups are not fully qualified.
Recalling firm
- Firm
- VistaPharm, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 7265 Ulmerton Rd, N/A, Largo, Florida 33771-4809
Distribution
- Quantity
- 84,100 Cups
- Distribution pattern
- U.S. Including: CA, IL, LA, OH, PA, and SC.
Timeline
- Recall initiated
- 2015-06-26
- FDA classified
- 2015-09-28
- Posted by FDA
- 2015-10-07
- Terminated
- 2017-02-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1831-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.