Food, drugs, devices › SCA Pharmaceuticals

Drug recall: Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx Only, SCA Pharmaceuticals 755 Rainbow Rd

FDA enforcement event 85865 · Class II · initiated 16 Jun 2020 · status Terminated · terminated 17 Mar 2021

DrugVoluntary: Firm initiated1 product recordWindsor, CT

FDA enforcement event 85865 is a drug recall by SCA Pharmaceuticals of Windsor, CT, initiated 16 Jun 2020 and classified Class II, with 1 product record.

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. 64% of the 342 drug enforcement events initiated in 2020 carry the same class.

Status: Terminated, terminated 17 Mar 2021. 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, Windsor, CT.

Reason for recall

"Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint."

Distribution

"Product was distributed to hospitals in PA and CA."

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-1311-2020	Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx Only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0650-46	333 bags	Class II	Terminated	24 Jun 2020

Context

64%of 2020 drug events are Class II342 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
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
7 Dec 2017	Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe, Total Volume 10 mL, Rx only, SCA Pharmac	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: "Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint."

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: "Product was distributed to hospitals in PA and CA."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 17 Mar 2021. "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.