Labeler · US market

AuroMedics Pharma LLC

AuroMedics Pharma LLC is a US drug labeler with US FDA registrations covering 7 drug concepts (7 currently active) across 16 packages.

ACTIVE — US

openFDA · updated weekly

Labeler codes55150

Active drugs7

Registrations13 active / 13

Packages16

Sole supplier of0 drugs

Portfolio7 drugs · US

Every drug concept this labeler has US registrations for, by package count.

Drug	Type	NDCs	Packages	Status
Glycopyrrolate injection, solution	rx	4	4	SUPPLYING
Cyanocobalamin injection, solution	rx	1	3	SUPPLYING
Amiodarone Hydrochloride injection, solution	rx	3	3	SUPPLYING
Dexrazoxane kit	rx	1	2	SUPPLYING
Atracurium Besylate injection, solution	rx	2	2	SUPPLYING
Sodium Nitroprusside injection	rx	1	1	SUPPLYING
Zoledronic Acid injection, solution, concentrate	rx	1	1	SUPPLYING

At a glance

TypeLabeler
Labeler codes55150
Filing names1
Drugs (active)7
Drugs (all time)7
US registrations13
Packages16

Recent events

Shortages, recalls, and registration changes across all filing names.

Sep 30, 2022
RECALLRecall (Class II): Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharm…
Sep 26, 2022
RECALLRecall (Class III): Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedic…
Sep 26, 2022
RECALLRecall (Class II): Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LL…
Apr 5, 2022
RECALLRecall (Class III): Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for …
Jan 26, 2022
RECALLRecall (Class I): Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only, …
Dec 30, 2020
RECALLRecall (Class II): Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, For Intravenous Use Only, Distributed …
Feb 7, 2020
RECALLRecall (Class II): Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by: Aurobindo Pharma U…
Feb 7, 2020
RECALLRecall (Class III): Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intra…

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile; figures cover the entity across all its filing names.