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 3% and 5% LIP BALM and DICLOFENAC 5% SPF 30 LIP BALM
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: There are also CGMP Deviations.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
DICLOFENAC 3% and 5% LIP BALM and DICLOFENAC 5% SPF 30 LIP BALM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Drug: Diclofenac Category: Pain Relief & OTC Medication
- Recalling firm
- Synergy Rx
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0580-2017 · 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 Synergy Rx
All 2017 recalls
Class II · Moderate risk
Kojic Acid 8%/Azelaic Acid 15% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Intimate Bleaching Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Gentle Supreme Bleaching Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Custom Lightening/Brightening Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
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