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AuroMedics Pharma LLC

AuroMedics Pharma LLC Recalls

All product recalls associated with AuroMedics Pharma LLC.

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Recall Summary

Total Recalls

7

Past Year

0

Class I (Serious)

0

Most Recent

Sep 2022

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–7 of 7 recalls

Tranexamic Acid Injection (AuroMedics) – metal contamination (2022)

Presence of Particulate Matter: Piece of metal found in a vial

FDASep 26, 2022Nationwide• AuroMedics Pharma LLC

Ranitidine Syrup (AuroMedics) – NDMA Impurity (2019)

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

Class IIModerate

FDANov 6, 2019Nationwide• AuroMedics Pharma LLC

Ranitidine Capsules 150mg (AuroMedics) – NDMA Impurity (2019)

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

Moderate

FDANov 6, 2019Nationwide• AuroMedics Pharma LLC

Ranitidine Capsules 300mg (AuroMedics) – NDMA Impurity (2019)

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

Class IIModerate

FDANov 6, 2019Nationwide• AuroMedics Pharma LLC

DG Health Acid Reducer (AuroMedics) – NDMA Impurity (2019)

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

Class IIModerate

FDANov 6, 2019Nationwide• AuroMedics Pharma LLC

Ranitidine Capsules 150mg (AuroMedics) – NDMA Impurity (2019)

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

Class IIModerate

FDANov 6, 2019Nationwide• AuroMedics Pharma LLC

Ranitidine Tablets 150mg (AuroMedics) – Empty Bottles (2019)

CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.

FDASep 23, 2019Nationwide• AuroMedics Pharma LLC