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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70564

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

Open FDA event record

Event summary

Timeline bucket
February 18, 2015
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Mylan Institutional 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

Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409-00) packaged in cartons of five (NDC 67457-409-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103

D-0421-2015
Recall number
D-0421-2015
Initiated
February 18, 2015
Classification
Class II
Status
Terminated
Recalling firm
Mylan Institutional LLC
Quantity
11,030 cartons (55,150 vials)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; due to leaking vials

Code information

Lot 7602281, Exp 4/16; Lot 7602283, Exp 4/16

Distribution pattern

Nationwide and Puerto Rico

drug · product 2 of 2

Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-00) packaged in cartons of ten (NDC 67457-410-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103

D-0422-2015
Recall number
D-0422-2015
Initiated
February 18, 2015
Classification
Class II
Status
Terminated
Recalling firm
Mylan Institutional LLC
Quantity
2,523 cartons (25,936 vials)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; due to leaking vials

Code information

Lot 7602368, Exp 7/16; Lot 7602369, Exp 7/16

Distribution pattern

Nationwide and Puerto Rico