Diclofenac Sodium Topical Solution recalled by Teligent Pharma
Teligent Pharma is recalling all unexpired batches of Diclofenac Sodium Topical Solution 1.5% due to current good manufacturing practice (cGMP) deviations related to discontinuation of the firm's stability study program.
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: This is an FDA Class II recall involving a manufacturing practice deviation (discontinuation of stability studies) rather than a direct safety hazard with reported injuries or illnesses. The source text states no adverse events, making this a precautionary/compliance-based recall typical of Class II classifications.
Plain-English summary
Teligent Pharma, Inc. is recalling Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles (NDC 52565-002-05) distributed nationwide in the USA and Puerto Rico. The recall affects approximately 16,643 bottles.
The recall is being issued because the manufacturer is discontinuing its stability study program, which represents a deviation from current good manufacturing practice (cGMP) requirements. All products within their expiration dates are affected by this recall.
Affected batches include: Batch 15066 and 15389 (expiration 3/31/2023); Batch 15437 (expiration 12/31/2023); Batch 16823 (expiration 4/30/2024); and Batches 16825 and 16826 (expiration 4/30/2024).
Patients and healthcare providers who have this product should contact Teligent Pharma, Inc. or consult their healthcare provider regarding alternative treatment options.
The recalled product
- Product
- Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-002-05.
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical Solution
- Hazard
- cgmp-deviation
- stability-data-gap
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 (8)
- Batch: 15066
- 15389 Exp. 3/31/2023
- 15437
- Exp. 12/31/2023
- 16823
- Exp. 4/30/2024
- 16825
- 16826
Distribution
Distributed nationwide across the United States.
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