PlainRecalls
FDA Drug Moderate Class II Terminated

Desoximetasone Ointment USP, 0.05%, Net Wt. 100 grams tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-037-10.

Reported: March 30, 2022 Initiated: March 15, 2022 #D-0676-2022

Product Description

Desoximetasone Ointment USP, 0.05%, Net Wt. 100 grams tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-037-10.

Reason for Recall

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

Details

Recalling Firm
Teligent Pharma, Inc.
Units Affected
6850 tubes
Distribution
Nationwide in the USA and Puerto Rico
Location
Buena, NJ

Frequently Asked Questions

What product was recalled?
Desoximetasone Ointment USP, 0.05%, Net Wt. 100 grams tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-037-10.. Recalled by Teligent Pharma, Inc.. Units affected: 6850 tubes.
Why was this product recalled?
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 30, 2022. Severity: Moderate. Recall number: D-0676-2022.