Drug recall: Droperidol injection, 2.5 mg/mL, 5 mg Total Dose, 2 mL Fill Volume per syringe, packaged in 10-count syringes per heat…

Class II FDA enforcement event 70583. Recall start date: 24 Feb 2015. Status in the FDA record: Terminated. Termination date: 9 Dec 2016.

Reason for recall, in the words of FDA

Presence of particulate.

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

SCA Pharmaceuticals started this drug recall on 24 Feb 2015. The firm address in the FDA record is in Little Rock, AR. FDA put the recall in Class II. FDA event 70583 has 1 product record. The first FDA enforcement report date is 29 Apr 2015. The record gives the status Terminated, with the termination date 9 Dec 2016.

FDA enforcement report The 1 product record

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.

IN, AR, MO, MN

Recalling firm

SCA Pharmaceuticals, Little Rock, AR.

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

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

Products

1 product record in the event.

FDA event 70583: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0965-2015	Droperidol injection, 2.5 mg/mL, 5 mg Total Dose, 2 mL Fill Volume per syringe, packaged in 10-count syringes per heat sealed bag, RX only; Compounded for Office Use by SCA Pharmaceuticals, Little Rock, AR (877 ) 550-5059 Bar Code 88888-7720-16	421 syringes	Class II	Terminated	29 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: 1Median of the firm: 1
Events of the firm on the register: 19

Other events of the firm

Other FDA enforcement events of SCA Pharmaceuticals
Initiated	Product (first record)	Type	Class	Records
20 Jul 2023	FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL C	Drug	Class II	1
10 Apr 2023	Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor, CT	Drug	Class III	1
24 Feb 2023	Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only,	Drug	Class III	1
25 Apr 2022	Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-078-40	Drug	Class II	3
17 Dec 2020	Atropine Sulfate Injection, 0.8 mg/2 mL (0.4 mg/mL), 2 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow	Drug	Class II	32
20 Nov 2020	Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205	Drug	Class III	1
29 Jul 2020	Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use	Drug	Class I	4
29 Jul 2020	Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx only, SCA Pharmaceuticals 755 Rainbow Rd	Drug	Class II	1
16 Jun 2020	Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx Only, SCA Pharmaceuticals 755 Rainbow Rd	Drug	Class II	1
29 Jun 2018	Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (Concentration=10 mg/mL) 0.25 mL Total	Drug	Class II	1

SCA Pharmaceuticals: all 19 events

Official channels

FDA enforcement report D-0965-2015The 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.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 70583. https://recallregister.com/fda/ii/70583/. 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: IN, AR, MO, MN
What quantity of product is in FDA event 70583?: The FDA record gives this quantity: 421 syringes
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.