Recalls / Class II
Class IID-0680-2022
Product
Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles, Rx Only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-025-05.
- Affected lot / code info
- Batch: 15384, Exp. 3/31/2023; 15646, Exp. 5/31/2023; 15971, Exp. 9/30/2023; 16206, 16226, Exp. 11/30/2023; 16268, Exp. 12/31/2023; 16342, 16343, Exp. 1/31/2024; 16503, 16504, Exp. 3/31/2024; 16632, Exp. 4/30/2024; 16715, 16731, Exp. 5/31/2024
Why it was recalled
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Recalling firm
- Firm
- Teligent Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 105 Lincoln Avenue, N/A, Buena, New Jersey 08310
Distribution
- Quantity
- 36,018 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2022-03-15
- FDA classified
- 2022-03-21
- Posted by FDA
- 2022-03-30
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0680-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.