Exact FDA event identifier

Event 84927

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket: February 07, 2020
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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 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 1

Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intravenous Use, Not for Use in Newborns, Contains Benzyl Alcohol, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ, 08520, Made in India, NDC 55150-295-20.

D-0853-2020

Recall number: D-0853-2020
Initiated: February 07, 2020
Classification: Class III
Status: Terminated
Recalling firm: AuroMedics Pharma LLC
Quantity: 4600 Vials

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).

Code information

Lot #CGP190001-A, Exp. 07/31/2020

Distribution pattern

Ohio, Louisiana, Mississippi