Domperidone 10 mg Capsules Recalled for Lack of Processing Controls
Duren Health Mart Pharmacy is recalling 840 capsules of Domperidone 10 mg due to a lack of processing controls. The product was distributed in Tennessee.
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, which typically involves a risk of temporary or medically reversible health consequences. The specific hazard is a lack of processing controls, which is a quality issue rather than a confirmed contamination or injury event.
Plain-English summary
Duren Health Mart Pharmacy is recalling 840 capsules of Domperidone 10 mg, NDC 00507-2011-00. The recall was initiated because of a lack of processing controls. The product is prescription-only and was distributed in Tennessee.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- Domperidone 10 mg capsules, 100-count per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00507-2011-00
- Manufacturer
- Duren Health Mart Pharmacy
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 840
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 (1)
- N/A
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 6 recalled by Duren Health Mart Pharmacy 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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