RecallRadar

FDA Drug recall D-0674-2022

Clobetasol Propionate Gel, 0.05%, packaged in a) 15 grams tube, NDC 52565-082-15

On 2022-03-30 the FDA classified a Class II recall of Clobetasol Propionate Gel, 0.05%, packaged in a) 15 grams tube, NDC 52565-082-15 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

AgencyFDA Drug
Recall numberD-0674-2022
ClassificationClass II
Statusterminated
Initiated2022-03-15
Published2022-03-30
Last updated2026-09-13 11:52 UTC
CompanyTeligent Pharma
DistributionUS

Product

Clobetasol Propionate Gel, 0.05%, packaged in a) 15 grams tube, NDC 52565-082-15; b) 30 grams tube, NDC 52565-082-30; c) 60 grams tube, NDC 52565-082-60, Rx Only, 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) 15063, Exp. 2/28/2022; 15928, Exp. 9/30/2022; 16432, Exp. 2/28/2023; 16769, Exp. 4/30/2023; b) 15243, Exp. 2/…Batch: a) 15063, Exp. 2/28/2022; 15928, Exp. 9/30/2022; 16432, Exp. 2/28/2023; 16769, Exp. 4/30/2023; b) 15243, Exp. 2/28/2022; 16628, Exp. 3/31/2023; c) 15064, 15286, 15287, Exp. 2/28/2022; 16173, Exp. 11/30/2022; 16628, Exp. 3/31/2023

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-0674-2022%22

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