Ingenus Recalls Diclofenac Sodium Topical Solution Due to Leaking Bottles
Ingenus Pharmaceuticals is recalling 29,435 bottles of Diclofenac Sodium Topical Solution because some bottles were found leaking.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is limited to packaging defects (leaking bottles) without reported injuries.
Plain-English summary
Ingenus Pharmaceuticals, LLC is recalling 29,435 bottles of Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only. The product was distributed nationwide in the USA and Puerto Rico.
The recall was initiated after the firm discovered samples stored horizontally and received product quality complaints from customers regarding bottles leaking. This is classified as an FDA Class III recall.
Consumers with this product should stop using it and contact their healthcare provider or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408, NDC 50742-308-05.
- Manufacturer
- Ingenus Pharmaceuticals Llc
- Category
- Drug — Topical Analgesic
- Hazard
- Affected units
- 29,435
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 (11)
- Lot #: 31804
- Exp 11/2019
- 31911
- 31917
- Exp 02/2020
- 32067
- 32072
- 32084
- Exp 06/2020
- 32248
- Exp 10/2020
Distribution
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