VistaPharm Recalls Metoclopramide Oral Solution Due to Leaking Containers
VistaPharm is recalling 322,650 cups of Metoclopramide Oral Solution because the containers leak when inverted.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a packaging defect (leaking) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
VistaPharm, Inc. is recalling 322,650 cups of Metoclopramide Oral Solution, USP 5 mg/5 mL (present as the hydrochloride), 10 mL cups. The product is prescription-only and was distributed nationwide in the U.S., including Puerto Rico.
The recall was initiated because the defective containers leak when inverted. The affected lots are 283700 (expiry 11/14), 291400 (expiry 01/15), and 303500 (expiry 04/15).
Consumers should stop using the product and contact their healthcare provider or pharmacist for instructions on how to dispose of or return the medication.
The recalled product
- 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.
- Manufacturer
- VistaPharm, Inc.
- Category
- Drug — Oral Solution
- Hazard
- Affected units
- 322,650
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot #: 283700
- Expiry: 11/14
- Lot #: 291400
- Expiry: 01/15
- and Lot #: 303500
- Expiry: 04/15.
Distribution
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