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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72527

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

Open FDA event record

Event summary

Timeline bucket
October 28, 2015
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Sanofi-Aventis U.S. 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

2 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 2

Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0025-5833-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5833-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ 08807 A Sanofi Company

D-0872-2016
Recall number
D-0872-2016
Initiated
October 28, 2015
Classification
Class I
Status
Terminated
Recalling firm
Sanofi-Aventis U.S. LLC
Quantity
383,900 prefilled syringes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Delivery System; potential to have inaccurate dosage delivery

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Delivery System; potential to have inaccurate dosage delivery

Code information

a) 2081278, 2113841, 2113842, 2144138, exp 10/2015; 2440675, exp 04/2016; 2506456, 2506460, 2546946, 2546947, exp 05/2016; 2620206, 2620207, 2659534, exp 06/2016; 2692111, 2692112, exp 07/2016; 2716517, 2719817, 2734079, 2734080, 2734081, 2778035, 2800128, exp 08/2016; 2800130, 2824828, 2824829, 2857516, 2867928, 2870928, 2867929, 2867930, 2883616, 2883617, exp 09/2016; 2883618, 2883619, 2974267, 2883620, 2945419, 2974269, exp 10/2016; 3026968, 3026969, exp 11/2016; 3026970, 3028227, 3032005, 3037217, 3037218, 3037219, exp 12/2016; b) 2299596, 03/2016

Distribution pattern

Nationwide

drug · product 2 of 2

Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0024-5831-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5831-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ 08807 A Sanofi Company

D-0873-2016
Recall number
D-0873-2016
Initiated
October 28, 2015
Classification
Class I
Status
Terminated
Recalling firm
Sanofi-Aventis U.S. LLC
Quantity
159,000 prefilled injectors

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Delivery System; potential to have inaccurate dosage delivery

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Delivery System; potential to have inaccurate dosage delivery

Code information

a) 2144144, exp 10/2015; 2469674, exp 04/2016; 2506492, 2546978, 2546979, exp 05/2016; 2654817, 2654818, exp 06/2016; 2692143, 2692144, exp 07/2016; 2719838, exp 08/2016; 2824845, 2891021, 2857530, exp 09/2016; 2883631, 2883632, exp 10/2016; 2883633, 2945429, 3028243, exp 11/2016; 3037230, 2966680, 2974276, 2974280, exp 12/2016; and b) 2525474, exp 05/2016

Distribution pattern

Nationwide