FDA Drug recall D-0670-2022

Clobetasol Propionate Cream USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-051-15

FDA Drug
Class II
terminated
Published 2022-03-30

On 2022-03-30 the FDA classified a Class II recall of Clobetasol Propionate Cream USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-051-15 by Teligent Pharma, citing cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-0670-2022
Classification	Class II
Status	terminated
Initiated	2022-03-15
Published	2022-03-30
Last updated	2026-09-13 11:52 UTC
Company	Teligent Pharma
Distribution	US

Product

Clobetasol Propionate Cream USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-051-15; b) 30 grams tube, NDC 52565-051-30; c) 45 grams tube, NDC 52565-051-45; d) 60 grams tube, NDC 52565-051-60; Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.

Reason

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

Identifiers

code_info	Batch: a) 15803, Exp. 7/31/2022; 16237, Exp. 11/30/2022; b) 15803, Exp. 7/31/2022; 16388, Exp. 2/28/2023; c) 15605, Exp… Batch: a) 15803, Exp. 7/31/2022; 16237, Exp. 11/30/2022; b) 15803, Exp. 7/31/2022; 16388, Exp. 2/28/2023; c) 15605, Exp. 7/31/2022; 16237, Exp. 11/30/2022; 16388, Exp. 2/28/2023; d) 15605, Exp. 7/31/2022; 15860, Exp. 8/31/2022; 16001, Exp. 9/30/2022; 16237, Exp. 11/30/2022; 16344, Exp. 1/31/2023; 16294, Exp. 2/28/2023; 16474, Exp. 2/28/2023; 16543, Exp. 2/28/2023.

code_info

Batch: a) 15803, Exp. 7/31/2022; 16237, Exp. 11/30/2022; b) 15803, Exp. 7/31/2022; 16388, Exp. 2/28/2023; c) 15605, Exp…

Batch: a) 15803, Exp. 7/31/2022; 16237, Exp. 11/30/2022; b) 15803, Exp. 7/31/2022; 16388, Exp. 2/28/2023; c) 15605, Exp. 7/31/2022; 16237, Exp. 11/30/2022; 16388, Exp. 2/28/2023; d) 15605, Exp. 7/31/2022; 15860, Exp. 8/31/2022; 16001, Exp. 9/30/2022; 16237, Exp. 11/30/2022; 16344, Exp. 1/31/2023; 16294, Exp. 2/28/2023; 16474, Exp. 2/28/2023; 16543, Exp. 2/28/2023.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0670-2022%22

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