VistaPharm Recalls Metoclopramide Oral Solution Due to Potential Water Contamination
VistaPharm is recalling specific lots of Metoclopramide Oral Solution because the purified water used in manufacturing may have been contaminated with Burkholderia cepacia.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk pathogen (Burkholderia cepacia) in a drug product where no illnesses or injuries have been reported, meeting the criteria for a High severity score.
Plain-English summary
VistaPharm, Inc. is recalling 3,496 unit dose cups of Metoclopramide Oral Solution, USP 10 mg/10 mL. The affected product is identified by Lot No. 428700 (Exp. 11/17) and Lot No. 409500 (Exp. 06/17). The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations.
The recall is necessary because the purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. This is a prescription-only medication distributed nationwide.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance on disposal or replacement.
The recalled product
- Product
- Metoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-031-50.
- Manufacturer
- VistaPharm, Inc.
- Category
- Drug — Oral Solution
- Affected units
- 3,496
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 No. 428700 (Exp. 11/17)
- 409500 (Exp.06/17)
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by VistaPharm, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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