Home / Recalls / Teligent Pharma, Inc. / D-0684-2022

D-0684-2022 Class II Terminated

Recalled by Teligent Pharma, Inc. — Buena, NJ

Recall Details

Product Type
Drugs
Report Date
March 30, 2022
Initiation Date
March 15, 2022
Termination Date
June 17, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
51,748 tubes

Product Description

Fluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) 60 g tubes, NDC 52565-054-60; c) 30 g tubes, NDC 52565-054-30, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310.

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: a) 15122, Exp. 2/28/2022; 15475, Exp. 3/31/2022; b) 15119, Exp. 2/28/2022; 15122, Exp. 2/28/2022; 15380, Exp. 3/31/2022; c) 15380, Exp. 3/31/2022

Other recalls by Teligent Pharma, Inc.

  • D-0670-2022 Class II — Clobetasol Propionate Cream USP, 0.05%, packaged in a) 15 grams tube, NDC 52565- (March 15, 2022)
  • D-0671-2022 Class II — Clobetasol Propionate Cream USP, 0.05% (Emollient), packaged in a) 15 grams tube (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-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-0687-2022 Class II — Gentamicin Sulfate Ointment USP 0.1%, packaged as a) 15 grams tube, NDC 52565-09 (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-0674-2022 Class II — Clobetasol Propionate Gel, 0.05%, packaged in a) 15 grams tube, NDC 52565-082-15 (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-0698-2022 Class II — Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx only, Te (March 15, 2022)