Home / Recalls / Teligent Pharma, Inc. / D-0064-2021

D-0064-2021 Class III Terminated

Recalled by Teligent Pharma, Inc. — Buena, NJ

Recall Details

Product Type
Drugs
Report Date
November 11, 2020
Initiation Date
September 28, 2020
Termination Date
August 22, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
36,790 tubes

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.

Distribution Pattern

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

Other recalls by Teligent Pharma, Inc.

  • D-0671-2022 Class II — Clobetasol Propionate Cream USP, 0.05% (Emollient), packaged in a) 15 grams tube (March 15, 2022)
  • D-0705-2022 Class II — Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 Oz) tube, Rx Only, Manufacture (March 15, 2022)
  • D-0670-2022 Class II — Clobetasol Propionate Cream USP, 0.05%, packaged in a) 15 grams tube, NDC 52565- (March 15, 2022)
  • D-0691-2022 Class II — Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx Only, Manufact (March 15, 2022)
  • D-0700-2022 Class II — Clobetasol Propionate Cream USP, 0.05%, packaged in 60 grams tube, Rx only, Manu (March 15, 2022)
  • D-0674-2022 Class II — Clobetasol Propionate Gel, 0.05%, packaged in a) 15 grams tube, NDC 52565-082-15 (March 15, 2022)
  • D-0699-2022 Class II — Triamcinolone Acetonide Ointment USP, 0.1%, packaged in a) 15 grams tubes, NDC 5 (March 15, 2022)
  • D-0685-2022 Class II — Fluocinonide Topical Solution USP, 0.05%, packaged in a) 20 mL bottles, NDC 5256 (March 15, 2022)
  • D-0687-2022 Class II — Gentamicin Sulfate Ointment USP 0.1%, packaged as a) 15 grams tube, NDC 52565-09 (March 15, 2022)
  • D-0698-2022 Class II — Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx only, Te (March 15, 2022)