Drug recall: Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409-00)…

Class II FDA enforcement event 70564. Recall start date: 18 Feb 2015. Status in the FDA record: Terminated. Termination date: 23 Feb 2017.

Reason for recall, in the words of FDA

Lack of Assurance of Sterility; due to leaking vials

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Mylan Institutional LLC started this drug recall on 18 Feb 2015. The firm address in the FDA record is in Rockford, IL. FDA put the recall in Class II. FDA event 70564 has 2 product records. The first FDA enforcement report date is 1 Apr 2015. The record gives the status Terminated, with the termination date 23 Feb 2017.

FDA enforcement report The 2 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide and Puerto Rico

Recalling firm

Mylan Institutional LLC, Rockford, IL.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

2 product records in the event.

FDA event 70564: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0421-2015	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	11,030 cartons (55,150 vials)	Class II	Terminated	1 Apr 2015
D-0422-2015	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	2,523 cartons (25,936 vials)	Class II	Terminated	1 Apr 2015

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2015: 292
Share of these events in Class II: 52%
Product records in this event: 2Median of the firm: 1
Events of the firm on the register: 11

Other events of the firm

Other FDA enforcement events of Mylan Institutional LLC
Initiated	Product (first record)	Type	Class	Records
3 May 2021	Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 25 (2 mL multi-dose vial) per carton, Rx onl	Drug	Class III	1
17 Aug 2020	Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-Dose Vial (NDC 67457-153-99); 10 x 9 mL Sin	Drug	Class I	2
7 Jul 2020	Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Manufactured for: Mylan Institutional, LLC, R	Drug	Class I	1
5 May 2020	Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC,	Drug	Class II	1
23 Apr 2015	Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-0152-01), packaged in 10 x 5 mL Vials per c	Drug	Class I	1
23 Mar 2015	Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-Use Vial, Rx only, labeled as a) Manufactur	Drug	Class I	3
18 Mar 2015	Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, packaged in 5 x 2 mL vials per carton, Rx only	Drug	Class I	1
18 Mar 2015	CARBOplatin Injection 450 mg/45 mL (10 mg/mL), 45 mL packaged in a 100 mL Multi-Dose Vial, Rx only, Manufactured for: My	Drug	Class I	1
11 Feb 2015	DOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 mg/mL), For IV Use Only, Sterile, ISOTONIC SOLUTION, Caution:	Drug	Class III	1
23 Jan 2015	Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for:	Drug	Class III	1

Mylan Institutional LLC: all 11 events

Official channels

FDA enforcement report D-0421-2015The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 70564. https://recallregister.com/fda/ii/70564/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide and Puerto Rico
What quantity of product is in FDA event 70564?: The event has 2 product records. The first record gives this quantity: 11,030 cartons (55,150 vials)
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2015 have the same class?: 52% of the 292 drug events that started in 2015 are in Class II.