Diclofenac Sodium Topical Solution recalled for defective container
Teligent Pharma, Inc. is recalling Diclofenac Sodium Topical Solution USP 1.5% due to a defective container. The recall affects 5,400 units distributed nationwide.
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 initiated voluntarily by the manufacturer. The source text identifies only a defective container as the hazard with no reports of illness or injury. Under the severity rubric, this falls under "Minor labeling errors, low-risk contamination, voluntary precautionary recalls," which corresponds to a Moderate classification.
Plain-English summary
Teligent Pharma, Inc. is voluntarily recalling Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl oz (150 mL) plastic bottles (NDC 70512-025-05) due to defective container issues. The recall affects 5,400 units distributed nationwide within the United States.
The affected product includes two lot numbers with the following expiration dates: Lot #15028, Exp 1/2023; and Lot #15379, Exp 3/2023. The defective container poses a potential risk to patients using this prescription medication.
Consumers with this product should contact their healthcare provider or pharmacist before using any remaining supply. Patients should not discontinue use of their medication without consulting their healthcare provider for guidance on alternative treatments.
The recalled product
- Product
- Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 70512-025-05.
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical Solution
- Hazard
- Affected units
- 5,400
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 (4)
- Lot #: 15028
- Exp 1/2023
- 15379
- Exp 3/2023.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Teligent Pharma, 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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