Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67838

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

Open FDA event record

Event summary

Timeline bucket
March 04, 2014
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Alkermes, Inc.

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

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

VIVITROL (naltrexone for extended-release injectable suspension); 380 mg vial NDC 65757-300-01; RX Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451.

D-1556-2014
Recall number
D-1556-2014
Initiated
March 04, 2014
Classification
Class II
Status
Terminated
Recalling firm
Alkermes, Inc.
Quantity
4,364 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Customer complaints for failure to deliver the dose.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Customer complaints for failure to deliver the dose.

Code information

Batch Number: 412-3732AA; expiration date 07/2016 (NDC# 65757-302-02; Kit Pacaging Lot Number: 2013-021; expiration date 07/2016 (NDC# 65757-300-01.

Distribution pattern

Nationwide