Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84240

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 11, 2019
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
AuroMedics Pharma LLC

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 3

Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-180-03

D-0520-2020
Recall number
D-0520-2020
Initiated
November 11, 2019
Classification
Class III
Status
Terminated
Recalling firm
AuroMedics Pharma LLC
Quantity
28,810 vials

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Crystallization: Presence of visible particulate matter.

Code information

Lot# CAH180009, exp. date Feb 2020

Distribution pattern

Distributed Nationwide in the US

drug · product 2 of 3

Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-181-09

D-0521-2020
Recall number
D-0521-2020
Initiated
November 11, 2019
Classification
Class III
Status
Terminated
Recalling firm
AuroMedics Pharma LLC
Quantity
29,830 vials

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Crystallization: Presence of visible particulate matter.

Code information

Lot# CAH180001, exp. date Jan 2020; CAH180003, exp. date Feb 2020; CAH180011, CAH180012, exp. date Jun 2020

Distribution pattern

Distributed Nationwide in the US

drug · product 3 of 3

Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-182-18

D-0522-2020
Recall number
D-0522-2020
Initiated
November 11, 2019
Classification
Class III
Status
Terminated
Recalling firm
AuroMedics Pharma LLC
Quantity
138,720 vials

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Crystallization: Presence of visible particulate matter.

Code information

Lot#: CAH180013, CAH180014, exp. date Jul 2020

Distribution pattern

Distributed Nationwide in the US