Why it was recalled
Defective Container: Product leaks when inverted.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 283700, Expiry: 11/14; Lot #: 291400, Expiry: 01/15; and Lot #: 303500, Expiry: 04/15.
Where it was sold
U.S. Nationwide, including Puerto Rico
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-0010-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 13, 2014
- FDA report date
- Oct 15, 2014
- Quantity
- 322,650 Cups
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- VistaPharm, Inc.
Original FDA data
Every field from FDA enforcement report D-0010-2015, exactly as published.
Show all FDA fields
- City
- Largo
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 69250
- Address
- 7265 Ulmerton Rd
- Code information
- Lot #: 283700, Expiry: 11/14; Lot #: 291400, Expiry: 01/15; and Lot #: 303500, Expiry: 04/15.
- Postal code
- 33771-4809
- Report date
- Oct 15, 2014
- Product type
- Drugs
- Recall number
- D-0010-2015
- Classification
- Class II
- Recalling firm
- VistaPharm, Inc.
- Product quantity
- 322,650 Cups
- Termination date
- Feb 24, 2015
- Reason for recall
- Defective Container: Product leaks when inverted.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- U.S. Nationwide, including Puerto Rico
- Recall initiation date
- Aug 13, 2014
- Initial firm notification
- Letter
- Center classification date
- Oct 9, 2014