Home / Recalls / Teligent Pharma, Inc. / D-0356-2021

D-0356-2021 Class II Ongoing

Recalled by Teligent Pharma, Inc. — Buena, NJ

FDA drug recall D-0356-2021 was initiated by Teligent Pharma, Inc. on April 9, 2021 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications: The recall status is ongoing. Affected quantity: 3432 tubes.

Recall Details

Product Type: Drugs
Report Date: April 28, 2021
Initiation Date: April 9, 2021
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3432 tubes

Product Description

Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310 NDC 52565-017-60

Reason for Recall

Failed Impurities/Degradation Specifications:

Distribution Pattern

Distributed Nationwide in the USA

Code Information

Lot #13974 EXP 7/2021

Other recalls by Teligent Pharma, Inc.

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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-0700-2022 Class II — Clobetasol Propionate Cream USP, 0.05%, packaged in 60 grams tube, Rx only, Manu (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-0688-2022 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-0676-2022 Class II — Desoximetasone Ointment USP, 0.05%, Net Wt. 100 grams tubes, Rx only, Manufactur (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)