Teligent Pharma, Inc.

59 FDA enforcement actions

59 Total Recalls

3 Class I

49 Class II

7 Class III

Firm Details

Product Types: drug
States: NJ

All Recalls

Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 03/15/2022 drug

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II: Risk 02/07/2022 drug

Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.
Class II: Risk 11/30/2021 drug

Superpotent Drug: Minimally superpotent
Class I: Dangerous 11/30/2021 drug

Superpotent Drug
Class II: Risk 10/19/2021 drug

Defective Container
Class II: Risk 10/19/2021 drug

Defective Container
Class I: Dangerous 10/12/2021 drug

Superpotent Drug
Class II: Risk 10/12/2021 drug

CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.
Class II: Risk 10/12/2021 drug

CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.
Class II: Risk 08/23/2021 drug

Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing
Class I: Dangerous 08/03/2021 drug

Superpotent Drug
Class III: Low Risk 07/29/2021 drug

Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.
Class II: Risk 07/29/2021 drug

Defective container: possibility for lack of seal integrity.
Class II: Risk 07/19/2021 drug

Correct Labeled Product Mispack
Class II: Risk 07/19/2021 drug

Correct Labeled Product Mispack
Class III: Low Risk 06/22/2021 drug

Failed Impurities/Degradation Specifications
Class III: Low Risk 06/22/2021 drug

Failed Impurities/Degradation Specifications
Class II: Risk 05/14/2021 drug

Presence of Foreign Substance: Foreign particles observed during routine stability testing.
Class II: Risk 04/09/2021 drug

Failed Impurities/Degradation Specifications:
Class III: Low Risk 03/29/2021 drug

Failed Stability Specifications: product did not meet viscosity results.
Class III: Low Risk 02/02/2021 drug

Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Class III: Low Risk 02/02/2021 drug

Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Class III: Low Risk 02/02/2021 drug

Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.