Recall archive
26 recalls · page 1 of 2
Reported Apr 3, 2024
Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.SCA Pharmaceuticals, LLC
Matched: Brand · Product · Product details — Lack of Assurance of Sterility
31 more products in this recall
FDA (openFDA drug enforcement)
Reported Aug 2, 2023
FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.SCA Pharmaceuticals
Matched: Brand · Product details — cGMP deviations: due to shipment of rejected units.
FDA (openFDA drug enforcement)
Reported May 3, 2023
Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.SCA Pharmaceuticals
Matched: Brand · Product · Product details — Subpotent Drug: Out of specification results for low potency was obtained.
FDA (openFDA drug enforcement)
Reported Mar 8, 2023
Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.SCA Pharmaceuticals
Matched: Brand · Product details — Subpotent Drug
FDA (openFDA drug enforcement)
Reported May 11, 2022
Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-078-40
Moderate riskThis product could cause temporary or reversible health problems — stop using it.SCA Pharmaceuticals
Matched: Brand · Product · Product details — CGMP Deviations
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Jan 13, 2021
Atropine Sulfate Injection, 0.8 mg/2 mL (0.4 mg/mL), 2 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.SCA Pharmaceuticals
Matched: Brand · Product · Product details — Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
31 more products in this recall
FDA (openFDA drug enforcement)
Reported Dec 30, 2020
Vasopressin 20 Units added to 0.9% Sodium Chloride 100 mL Rx Only, Single Dose Container, SCA Pharmaceuticals 8821…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.SCA Pharmaceuticals, Inc.
Matched: Brand · Product · Product details — Subpotent drug.
FDA (openFDA drug enforcement)
Reported Dec 23, 2020
Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.SCA Pharmaceuticals
Matched: Brand · Product · Product details — Subpotency: Out-of-specification stability test result for low potency was obtained.
FDA (openFDA drug enforcement)
Reported Sep 2, 2020
Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use…
High riskUsing this product could cause serious injury, illness or death — stop using it now.SCA Pharmaceuticals
Matched: Brand · Product details — Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained…
3 more products in this recall
FDA (openFDA drug enforcement)
Reported Aug 19, 2020
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx only, SCA Pharmaceuticals 755 Rainbow…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.SCA Pharmaceuticals
Matched: Brand · Product · Product details — Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
FDA (openFDA drug enforcement)
Reported Jun 24, 2020
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx Only, SCA Pharmaceuticals 755 Rainbow…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.SCA Pharmaceuticals
Matched: Brand · Product · Product details — Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
FDA (openFDA drug enforcement)
Reported Dec 18, 2019
Lidocaine HCl 2% 5 mL, Syringe, Rx Only, SCA Pharmaceuticals 755 Rainbow Road Windsor, CT 08695 NDC 70004-0723-09
Moderate riskThis product could cause temporary or reversible health problems — stop using it.SCA Pharmaceuticals, LLC
Matched: Brand · Product · Product details — Presence of Foreign Substance: Foreign material found inside the vial (manufacturer).
FDA (openFDA drug enforcement)
Reported Aug 28, 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…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.SCA Pharmaceuticals, LLC
Matched: Brand · Product details — Lack of Assurance of Sterility.
FDA (openFDA drug enforcement)
Reported Sep 19, 2018
Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection, 100 mL Single Dose Container bag, Rx Only, SCA…
High riskUsing this product could cause serious injury, illness or death — stop using it now.SCA Pharmaceuticals, Inc.
Matched: Brand · Product · Product details — Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.
FDA (openFDA drug enforcement)
Reported Jul 18, 2018
Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (Concentration=10 mg/mL) 0.25 mL Total…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.SCA Pharmaceuticals
Matched: Brand · Product details — Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding.
FDA (openFDA drug enforcement)
Reported Jul 11, 2018
Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syringe, SCA Pharmaceuticals, LLC, Windsor, CT
Moderate riskThis product could cause temporary or reversible health problems — stop using it.SCA Pharmaceuticals, LLC
Matched: Brand · Product · Product details · Reason for recall — Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
11 more products in this recall
FDA (openFDA drug enforcement)
Reported Mar 14, 2018
labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.SCA Pharmaceuticals, LLC.
Matched: Brand · Product · Product details — Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date…
FDA (openFDA drug enforcement)
Reported Jan 17, 2018
Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe, Total Volume 10 mL, Rx only, SCA…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.SCA Pharmaceuticals
Matched: Brand · Product · Product details — Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and beyond use date.
FDA (openFDA drug enforcement)
Reported Nov 8, 2017
SUCcinylcholine 20 mg per mL, Total Volume 10 mL in single-dose syringe, (SUCcinylcholine 200 mg / 10 ml) Rx Only, SCA…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.SCA Pharmaceuticals, LLC
Matched: Brand · Product · Product details — Lack Of Assurance Of Sterility.
9 more products in this recall
FDA (openFDA drug enforcement)
Reported Aug 2, 2017
morphine sulfate 1 mg per mL in 0.9% Sodium Chloride, (Total morphine Dose 100 mg/100 mL), Total Volume 100 mL Single…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.SCA Pharmaceuticals
Matched: Brand · Product details — Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
35 more products in this recall
FDA (openFDA drug enforcement)
Reported Jul 19, 2017
Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol (14.67 mEq K+) Total Approximate Volume 254 mL, Rx…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.SCA Pharmaceuticals
Matched: Brand · Product details — Lack of sterility assurance
3 more products in this recall
FDA (openFDA drug enforcement)
Reported Jun 7, 2017
morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.SCA Pharmaceuticals
Matched: Brand · Product details — Lack of assurance of sterility: Product bags leaking at seam.
9 more products in this recall
FDA (openFDA drug enforcement)
Reported Apr 12, 2017
Vancomycin HCl 1.25 g added to 5% Dextrose 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR…
High riskUsing this product could cause serious injury, illness or death — stop using it now.SCA Pharmaceuticals
Matched: Brand · Product · Product details — Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate…
6 more products in this recall
FDA (openFDA drug enforcement)
Reported Jun 17, 2015
PHENYLephrine HCl 50 mg in 0.9% Sodium Chloride 250 mL bag (Concentration = 0.2 mg per mL), Rx only, SCA…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.SCA Pharmaceuticals
Matched: Brand · Product · Product details — 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.
FDA (openFDA drug enforcement)
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