Promethazine Gel Recalled by Duren Health Mart Pharmacy for Processing Control Issues
Duren Health Mart Pharmacy is recalling Promethazine Gel 50 mg/mL due to a lack of processing controls. The affected product was distributed in Tennessee.
What this means for you
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 indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific hazard is a lack of processing controls, which is a quality issue rather than a direct, reported injury or high-risk pathogen.
Plain-English summary
Duren Health Mart Pharmacy is recalling Promethazine Gel 50 mg/mL, a prescription-only medication. The recall was initiated due to a lack of processing controls. The product is identified by NDC 00002-1901-03 and was available in quantities ranging from 1cc to 10cc per prescription.
The recall involves 876 cc of the product. Distribution was limited to Tennessee. The agency has classified this recall as Class II.
Consumers who have this product should contact their healthcare provider or the pharmacy for further instructions on how to proceed.
The recalled product
- Product
- Promethazine Gel 50 mg/mL, 1cc to 10cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00002-1901-03
- Manufacturer
- Duren Health Mart Pharmacy
- Category
- Drug — Pharmacy Compounded
- Hazard
- Affected units
- 876
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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