Home / Recalls / Teligent Pharma, Inc. / D-0700-2022

D-0700-2022 Class II Terminated

Recalled by Teligent Pharma, Inc. — Buena, NJ

FDA drug recall D-0700-2022 was initiated by Teligent Pharma, Inc. on Mar 15, 2022 and is designated Class II. Reason for recall: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. The recall status is terminated (terminated Jun 17, 2024). Affected quantity: 26,326 tubes.

Recall Details

Product Type: Drugs
Report Date: Mar 30, 2022
Initiation Date: Mar 15, 2022
Termination Date: Jun 17, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 26,326 tubes

Product Description

Clobetasol Propionate Cream USP, 0.05%, packaged in 60 grams tube, Rx only, Manufactured for SOLA Pharmaceuticals, Baton Rouge, LA 70809; NDC 70512-028-60.

Reason for Recall

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

Distribution Pattern

Nationwide in the USA and Puerto Rico

Code Information

Batch: 16001 Exp. 9/30/2022; 16089 Exp. 11/30/2022

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0700-2022
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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