Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Defective Container: Leaking containers.
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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
Reason Failed PH Specifications
Reason Defective Delivery System
Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability…
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.