Progesterone Cream Recalled for Lack of Processing Controls
Duren Health Mart Pharmacy is recalling Progesterone 10% cream 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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity recall involving potential but unreported harm.
Plain-English summary
Duren Health Mart Pharmacy is recalling Progesterone 10% cream, 12gm to 30gm per prescription, due to a lack of processing controls. The product is prescription-only and was distributed in Tennessee.
The recall is being conducted by the U.S. Food and Drug Administration. The specific NDC for the product is 00000-0002-99. The source text does not specify the exact quantity of units recalled or the specific dates of distribution.
Consumers who have this product should contact their healthcare provider or the pharmacy for further instructions on how to proceed.
The recalled product
- Product
- Progesterone 10% cream, 12gm to 30gm per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00000-0002-99
- Manufacturer
- Duren Health Mart Pharmacy
- Category
- Drug — Topical Prescription
- Hazard
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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