Food, drugs, devices › SCA Pharmaceuticals

Drug recall: PHENYLephrine HCl 50 mg in 0.9% Sodium Chloride 250 mL bag (Concentration = 0.2 mg per mL), Rx only, SCA Pharmaceuticals

FDA enforcement event 71166 · Class II · initiated 28 Apr 2015 · status Terminated · terminated 9 Dec 2016

DrugVoluntary: Firm initiated1 product recordLittle Rock, AR

SCA Pharmaceuticals (Little Rock, AR) initiated this drug recall on 28 Apr 2015; FDA lists 1 product record under event 71166, classified Class II.

FDA defines Class II as 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. 52% of the 292 drug enforcement events initiated in 2015 carry the same class.

Status: Terminated, terminated 9 Dec 2016. Initiation: voluntary: firm initiated. SCA Pharmaceuticals has 19 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

SCA Pharmaceuticals, Little Rock, AR.

Reason for recall

"Labeling: Label Mix-Up: Product is incorrectly labeled as phenylephrine 50 mg in 0.9% sodium chloride rather than phenylephrine 50 mg in 5% dextrose."

Distribution

"CA"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-1133-2015	PHENYLephrine HCl 50 mg in 0.9% Sodium Chloride 250 mL bag (Concentration = 0.2 mg per mL), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR (877) 550-5059, barcode 88888772029.	50 bags	Class II	Terminated	17 Jun 2015

Context

52%of 2015 drug events are Class II292 events that year

1product record in this eventfirm median: 1

19events on this register for the firm

Other enforcement events for 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

All 19 events for SCA Pharmaceuticals

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Labeling: Label Mix-Up: Product is incorrectly labeled as phenylephrine 50 mg in 0.9% sodium chloride rather than phenylephrine 50 mg in 5% dextrose."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is 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.

Where was the product distributed?

FDA's distribution pattern field reads: "CA"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 9 Dec 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.