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 1.5%
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Defective Container: Leaking containers.
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%, 150 mL, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534 Mfg. For SOLA Pharmaceuticals Baton Rouge, LA, NDC 61919-675-05
Affected NDC
61919-0675-05
Compare with the code on your package — it is the most precise check available.
Drug: Diclofenac Category: Pain Relief & OTC Medication
- Recalling firm
- Direct Rx
- NDC code
- 61919-675-05
- Origin
- GA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0714-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. 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 Direct Rx
All 2021 recalls
Class II · Moderate risk
Duloxetine D/R
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · Moderate risk
Duloxetine D/R
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · Moderate risk
Duloxetine D/R
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · Moderate risk
Ciprofloxacin Ophth Solution
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
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