Drug recall: Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol (14.67 mEq K+) Total Approximate Volume 254 mL, Rx…

Class II FDA enforcement event 77600. Recall start date: 21 Jun 2017. Status in the FDA record: Terminated. Termination date: 3 Apr 2019.

Reason for recall, in the words of FDA

Lack of sterility assurance

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 21 Jun 2017. The firm address in the FDA record is in Little Rock, AR. FDA put the recall in Class II. FDA event 77600 has 4 product records. The first FDA enforcement report date is 19 Jul 2017. The record gives the status Terminated, with the termination date 3 Apr 2019.

FDA enforcement report The 4 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.

LA, PA, NY, WI

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

4 product records in the event.

FDA event 77600: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0976-2017	Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol (14.67 mEq K+) Total Approximate Volume 254 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0840-40	221 bags	Class II	Terminated	19 Jul 2017
D-0977-2017	Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0841-40	660 bags	Class II	Terminated	19 Jul 2017
D-0978-2017	Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0841-32	20 bags	Class II	Terminated	19 Jul 2017
D-0979-2017	Potassium PHOSphate added to 0.9% Sodium Chloride 250 mL Bag 30 mMol (44 mEq K+) Total Approximate Volume 260 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0843-40	20 bags	Class II	Terminated	19 Jul 2017

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 2017: 343
Share of these events in Class II: 57%
Product records in this event: 4Median 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-0976-2017The 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 77600. https://recallregister.com/fda/ii/77600/. 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: LA, PA, NY, WI
What quantity of product is in FDA event 77600?: The event has 4 product records. The first record gives this quantity: 221 bags
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2017 have the same class?: 57% of the 343 drug events that started in 2017 are in Class II.