Diclofenac Sodium Topical Solution recalled due to leaking containers
Direct Rx is recalling Diclofenac Sodium Topical Solution 1.5% (150 mL) nationwide due to defective containers that may leak. Consumers who have purchased this product should stop use and contact their pharmacy or physician.
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: This is an FDA Class II recall for a defective container issue. The source text does not report any illnesses, injuries, or hospitalizations. The hazard is a packaging defect (leaking containers) without reported harm, which meets the criteria for a Moderate severity rating.
Plain-English summary
Direct Rx is recalling Diclofenac Sodium Topical Solution 1.5%, 150 mL (NDC 61919-675-05, Lot #24MA2010, Exp. 1/31/2023) that was packaged and distributed nationwide within the United States. The recall was initiated because the containers are defective and may leak.
This is a prescription-only medication manufactured for SOLA Pharmaceuticals in Baton Rouge, Louisiana. A total of 312 bottles are affected by this recall.
Consumers who have purchased this product should stop using it and contact their pharmacy or physician for guidance. The defective containers pose a risk of product leakage, which may affect the integrity and safety of the medication.
The recalled product
- Product
- Diclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534 Mfg. For SOLA Pharmaceuticals Baton Rouge, LA, NDC 61919-675-05
- Manufacturer
- Direct Rx
- Category
- Drug — Topical Solution
- Affected units
- 312
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)
- Lot #: 24MA2010 Exp. 1/31/2023
Distribution
Distributed nationwide across the United States.
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