Windsor, CT, United States
SCA Pharmaceuticals recalls
18 recalls recorded since 2018, most recently on 9 November 2023. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls18
Ongoing (FDA)0
Terminated or completed18
Class I (FDA)2
Terminated Class II Drugs
- Recall started
- 9 November 2023
- Terminated
- 27 August 2024
- Reason
- Lack of Assurance of Sterility
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0417-2024, D-0411-2024, D-0410-2024, D-0419-2024, D-0399-2024, D-0402-2024, D-0407-2024, D-0418-2024, D-0424-2024, D-0395-2024, D-0403-2024, D-0413-2024 and 20 more
- PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-22, Bar Code 70004081022.
- labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0700-28, Bar Code 70004070028
- HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-21, Bar Code 70004030321
- PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0825-40, Bar Code 70004082540.
- fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT
- fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose Syringe, RX Only, repackaged by SCA Pharma. SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0200-17, Bar
- HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-22, Bar Code 70004030022
- PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0811-12, Bar Code 70004
- and 24 more product lines
Terminated Class II Drugs
- Recall started
- 20 July 2023
- Terminated
- 21 September 2023
- Reason
- cGMP deviations: due to shipment of rejected units.
- Distribution
- KY and NJ
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0945-2023
- FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 755 Rainbow Rd, Winds
Terminated Class III Drugs
- Recall started
- 10 April 2023
- Terminated
- 20 September 2023
- Reason
- Subpotent Drug: Out of specification results for low potency was obtained.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0555-2023
- Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor, CT 06095, NDC# 70004-085-44
Terminated Class III Drugs
- Recall started
- 24 February 2023
- Terminated
- 21 June 2023
- Reason
- Subpotent Drug
- Distribution
- Nationwide in the US.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0363-2023
- Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor CT 06095, NDC# 70004-0200-16.
Terminated Class II Drugs
- Recall started
- 25 April 2022
- Terminated
- 9 September 2022
- Reason
- CGMP Deviations
- Distribution
- Product was distributed nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0831-2022, D-0829-2022, D-0830-2022
- Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0924-44
- Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-078-40
- Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0231-32
Terminated Class II, Class III Drugs
- Recall started
- 17 December 2020
- Terminated
- 2 November 2021
- Reason
- Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- Distribution
- Product was distributed to hospitals nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0215-2021, D-0189-2021, D-0216-2021, D-0213-2021, D-0191-2021, D-0207-2021, D-0202-2021, D-0188-2021, D-0190-2021, D-0194-2021, D-0214-2021, D-0186-2021 and 20 more
- HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection, CII, Rx Only, 50 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004030022
- ePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection, 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004060412
- PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081022
- ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals 8521 Knoedl Ct., Little Rock, AR, 72205, barcode 70004060409
- fentaNYL 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004026422
- Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL), Rx only, 3 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090025
- morphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection, (5 mg/mL), Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010316
- ePHEDrine Sulfate, 50 mg/5mL in 0.9% Sodium Chloride Injection, 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004060509
- and 24 more product lines
Terminated Class II Drugs
- Recall started
- 14 December 2020
- Terminated
- 23 September 2021
- Reason
- Subpotent drug.
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0171-2021
- Vasopressin 20 Units added to 0.9% Sodium Chloride 100 mL Rx Only, Single Dose Container, SCA Pharmaceuticals 8821 Knoedl Ct. Little Rock, AR 72205 Bar Code 70004093232
Terminated Class III Drugs
- Recall started
- 20 November 2020
- Terminated
- 24 June 2021
- Reason
- Subpotency: Out-of-specification stability test result for low potency was obtained.
- Distribution
- Product was distributed to three hospitals in MO & LA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0147-2021
- Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205
Terminated Class I Drugs
- Recall started
- 29 July 2020
- Terminated
- 21 May 2021
- Reason
- Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
- Distribution
- Nationwide within the U.S.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1553-2020, D-1550-2020, D-1552-2020, D-1551-2020
- Heparin Sodium 10,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0652-46, Bar C
- Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0655-44, Bar Code
- Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-46, Bar Cod
- Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-44, Bar Cod
Terminated Class II Drugs
- Recall started
- 29 July 2020
- Terminated
- 17 March 2021
- Reason
- Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
- Distribution
- Product was distributed nationwide within the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1495-2020
- 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
Terminated Class II Drugs
- Recall started
- 16 June 2020
- Terminated
- 17 March 2021
- Reason
- Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
- Distribution
- Product was distributed to hospitals in PA and CA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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
Terminated Class II Drugs
- Recall started
- 26 November 2019
- Terminated
- 7 February 2020
- Reason
- Presence of Foreign Substance: Foreign material found inside the vial (manufacturer).
- Distribution
- nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0620-2020
- Lidocaine HCl 2% 5 mL, Syringe, Rx Only, SCA Pharmaceuticals 755 Rainbow Road Windsor, CT 08695 NDC 70004-0723-09
Terminated Class II Drugs
- Recall started
- 16 August 2019
- Terminated
- 15 October 2019
- Reason
- Lack of Assurance of Sterility.
- Distribution
- Nationwide in the U.S.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1843-2019
- Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe, Rx Only, SCA Pharmaceuticals, Windsor, CT 06095, NDC 70004-0430-09.
Terminated Class I Drugs
- Recall started
- 27 August 2018
- Terminated
- 2 June 2020
- Reason
- Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.
- Distribution
- Three hospitals in DC, VA, CT
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1189-2018
- Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection, 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205, 877.550.5059, barcode 70004063032.
Terminated Class II Drugs
- Recall started
- 29 June 2018
- Terminated
- 1 May 2019
- Reason
- Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding.
- Distribution
- United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0918-2018
- Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (Concentration=10 mg/mL) 0.25 mL Total Volume, Rx only , SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205 877-550-5059
Terminated Class II Drugs
- Recall started
- 14 June 2018
- Terminated
- 4 February 2019
- Reason
- Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
- Distribution
- Product was distributed throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0899-2018, D-0897-2018, D-0901-2018, D-0903-2018, D-0894-2018, D-0895-2018, D-0898-2018, D-0900-2018, D-0904-2018, D-0896-2018, D-0902-2018, D-0905-2018
- Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
- Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume 125 mL) (125 mg), SCA Pharmaceuticals, LLC, Windsor, CT
- Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
- Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
- Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syringe, SCA Pharmaceuticals, LLC, Windsor, CT
- Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
- Norepinephrine Bitartrate 4 mg (16 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
- Norepinephrine Bitartrate 16 mg (64 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
- and 4 more product lines
Terminated Class III Drugs
- Recall started
- 22 February 2018
- Terminated
- 26 February 2019
- Reason
- Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and use-by-date of 03/27/2018
- Distribution
- GA, NE & PA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0603-2018
- labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095 --- NDC 70004-0700-28, UPC 70004070028
Terminated Class II Drugs
- Recall started
- 7 December 2017
- Terminated
- 1 May 2019
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and beyond use date.
- Distribution
- U.S.A. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0156-2018
- Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe, Total Volume 10 mL, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0600-12
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.