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Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-15, b) 30 gm tube, N...

FDA Recall #D-0064-2021 — Class III — September 28, 2020

Recall #D-0064-2021 Date: September 28, 2020 Classification: Class III Status: Terminated

Product Description

Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-15, b) 30 gm tube, NDC 52565-0040-30 c) 60 gram tube, NDC 52565-0040-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310

Reason for Recall

Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.

Recalling Firm

Teligent Pharma, Inc. — Buena, NJ

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

36,790 tubes

Distribution

United States Nationwide

Code Information

Lot#: a) 12250, Exp 10/2020; 15039, Exp 1/2022; 15573, Exp 7/2022; b) 12250, Exp 10/2020; 14589, 14848, Exp 12/2021; 15039, Exp 1/2022; 15245, Exp 2/2022; c) 12241, 12249, Exp 10/2020; 14222, Exp 8/2021; 15039, Exp 1/2022; 15037, 15246, Exp 2/2022; 15340, Exp 3/2022; 15387, Exp 4/2022

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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