Teligent Pharma Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle recall — FDA D-0690-2022
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Overview of recall records associated with Teligent Pharma, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 43, Class III: 3, Class I: 1.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.
Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing
Superpotent Drug: Minimally superpotent
Superpotent 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.
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.
Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.
Presence of Foreign Substance: Foreign particles observed during routine stability testing.
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
This page summarizes recall records in which the official source identifies Teligent Pharma, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.