VistaPharm Recalls Metoclopramide Oral Solution Due to Defective Container Lids
VistaPharm is recalling 84,100 cups of Metoclopramide Oral Solution because the unit dose cup lids are not fully qualified.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The defect is limited to container qualification.
Plain-English summary
VistaPharm, Inc. is recalling 84,100 cups of Metoclopramide Oral Solution, USP 10 mg/10 mL, 10 mL cups, prescription only. The product is identified by NDC 66689-031-01, Lot # 387500, and an expiration date of 01/17.
The recall was initiated because the lids on the unit dose cups are not fully qualified. This is a Class III recall, indicating that the defect is not likely to cause adverse health consequences.
The affected product was distributed in the United States, including California, Illinois, Louisiana, Ohio, Pennsylvania, and South Carolina. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions.
The recalled product
- Product
- METOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, 10 mL cups, Rx only. Manufactured by VistaPharm, Inc, Largo, FL. NDC: 66689-031-01.
- Manufacturer
- VistaPharm, Inc.
- Category
- Drug — Oral Solution
- Hazard
- Affected units
- 84,100
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 (2)
- Lot #: 387500
- Expiry: 01/17
Distribution
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