Home / Recalls / Teligent Pharma, Inc. / D-0697-2022

D-0697-2022 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
721,225 tubes; 90,893 jars

Product Description

Triamcinolone Acetonide Cream USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-056-15; b) 30 grams tubes, NDC 52565-056-30; c) 80 grams tubes, NDC 52565-056-80, d) 1 lb (454 g) jars, NDC 52565-056-26; Rx Only, Teligent Pharma, Inc., Buena, New Jersey 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) 15123, Exp. 2/28/2022; 15875, Exp. 8/31/2022; 16115, Exp. 10/31/2022; b) 15123, 15201, Exp. 2/28/2022; 15477, Exp. 4/30/2022; 15897, Exp. 8/31/2022; 16090, Exp. 10/31/2022; 16374, Exp. 1/31/2023; 16676, Exp. 3/31/2023; 17109, Exp. 7/31/2023; c) 15241, Exp. 2/28/2022; 16610, Exp. 3/31/2023; d) 15121, 15127, 15191, 15201, 15278, Exp. 2/28/2022;15386, 15567, Exp. 4/30/2022; 15875, Exp. 8/31/2022; 16050, 16051, 16115, Exp. 10/31/2022; 16165, 16201, Exp. 11/30/2022; 16609, 16610, 16624, Exp. 3/31/2023; 16700, Exp. 4/30/2023; 16732, Exp. 5/31/2023; 17081, 17108, Exp. 7/31/2023

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-0699-2022 Class II — Triamcinolone Acetonide Ointment USP, 0.1%, packaged in a) 15 grams tubes, NDC 5 (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-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-0691-2022 Class II — Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx Only, Manufact (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-0685-2022 Class II — Fluocinonide Topical Solution USP, 0.05%, packaged in a) 20 mL bottles, NDC 5256 (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-0682-2022 Class II — Econazole Nitrate Cream, 1%, packaged in a) 15 grams tubes, NDC 52565-022-15; b) (March 15, 2022)
  • D-0671-2022 Class II — Clobetasol Propionate Cream USP, 0.05% (Emollient), packaged in a) 15 grams tube (March 15, 2022)