Class II · Moderate risk
Diclofenac Sodium
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
Diclofenac Sodium Topical Solution
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
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.
Affected NDC
50742-0308-05
Compare with the code on your package — it is the most precise check available.
Drug: Diclofenac Category: Pain Relief & OTC Medication
- Recalling firm
- Ingenus Pharmaceuticals Llc
- NDC code
- 50742-308-05
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1058-2019 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Diclofenac recalls
See all
Class III · Low risk
Diclofenac Sodium Topical Gel
Failed PH Specifications
Class II · Moderate risk
Diclofenac Sodium Topical Solution USP
Defective Delivery System
Class II · Moderate risk
Diclofenac Sodium Topical Solution 1.5% w/w
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
Class II · Moderate risk
Diclofenac Sodium Topical Solution USP
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Other recalls by Ingenus Pharmaceuticals Llc
All 2019 recalls
Class II · Moderate risk
Flunisolide Nasal Solution
Out of specification for related substances (impurities).
Class II · Moderate risk
Clobetasol Propionate Foam
CGMP Deviations
Class II · Moderate risk
Leucovorin Calcium Injection
Crystallization: Presence of particulate matter identified as API crystallization
Class II · Moderate risk
Irinotecan Hydrochloride Injection
Superpotent Drug: High out of specification assay value results for potency.
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