Records and reported status
Nov 9, 2023 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: Nationwide in the USA
Official source for Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx o... Nov 9, 2023 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: Nationwide in the USA
Official source for fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL B... Nov 9, 2023 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: Nationwide in the USA
Official source for fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag, ... Nov 9, 2023 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: Nationwide in the USA
Official source for fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNY... Nov 9, 2023 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: Nationwide in the USA
Official source for fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection, (fentaN... Nov 9, 2023 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: Nationwide in the USA
Official source for fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL ... Nov 9, 2023 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: Nationwide in the USA
Official source for fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL... Nov 9, 2023 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: Nationwide in the USA
Official source for fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection (fentaNY... Nov 9, 2023 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: Nationwide in the USA
Official source for fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose... Nov 9, 2023 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: Nationwide in the USA
Official source for fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Sin... Nov 9, 2023 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: Nationwide in the USA
Official source for HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20 mg... Nov 9, 2023 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: Nationwide in the USA
Official source for HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 0.2 mg/ml) 30 mL... Nov 9, 2023 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: Nationwide in the USA
Official source for HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, R... Nov 9, 2023 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: Nationwide in the USA
Official source for HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL... Nov 9, 2023 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: Nationwide in the USA
Official source for HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL ... Nov 9, 2023 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: Nationwide in the USA
Official source for HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentration = 1 mg/ml) 30 mL f... Nov 9, 2023 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: Nationwide in the USA
Official source for HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL f... Nov 9, 2023 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: Nationwide in the USA
Official source for labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharm... Nov 9, 2023 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: Nationwide in the USA
Official source for Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 100 mL Ba... Nov 9, 2023 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported terminated
Distribution: Nationwide in the USA
Official source for neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL Syringe, ...
Reasons in these listed records Lack of Assurance of Sterility These examples come from this result page and are not a ranking of every recall reason.
Checking SCA Pharmaceuticals, LLC Is there a recall on sca pharmaceuticals, llc right now? This archive contains 32 records, including 0 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Where can I find older records? Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.