Recalls / Class II
Class IID-0714-2022
Product
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 lot / code info
- Lot #: 24MA2010 Exp. 1/31/2023
Why it was recalled
Defective Container: Leaking containers.
Recalling firm
- Firm
- Direct Rx
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 94 Worldwide Dr, N/A, Dawsonville, Georgia 30534-6828
Distribution
- Quantity
- 312 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2021-12-07
- FDA classified
- 2022-03-22
- Posted by FDA
- 2022-03-30
- Terminated
- 2023-10-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0714-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.