FDA-Drug2022-03-30Class II

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.

Teligent Pharma, Inc.
Hazard

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Sold states
Nationwide in the USA and Puerto Rico
Affected count
36,018 bottles
Manufactured in
105 Lincoln Avenue, N/A, Buena, NJ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0680-2022

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