Records and reported status
Mar 31, 2025 FDA drug enforcement
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II Reported ongoing
Distribution: Nationwide in the U.S.A
Official source for Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 1379... Mar 31, 2025 FDA drug enforcement
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II Reported ongoing
Distribution: Nationwide in the U.S.A
Official source for dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5m... Mar 31, 2025 FDA drug enforcement
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II Reported ongoing
Distribution: Nationwide in the U.S.A
Official source for PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe,... Mar 31, 2025 FDA drug enforcement
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II Reported ongoing
Distribution: Nationwide in the U.S.A
Official source for Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796... Mar 31, 2025 FDA drug enforcement
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II Reported ongoing
Distribution: Nationwide in the U.S.A
Official source for Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health,... Feb 20, 2024 FDA drug enforcement
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Class II Reported ongoing
Distribution: Nationwide in the USA
Official source for Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral ... Feb 20, 2024 FDA drug enforcement
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Class II Reported ongoing
Distribution: Nationwide in the USA
Official source for Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood,... Feb 20, 2024 FDA drug enforcement
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Class II Reported ongoing
Distribution: Nationwide in the USA
Official source for Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Onl... Dec 28, 2023 FDA drug enforcement
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I Reported ongoing
Distribution: Nationwide within the United States
Official source for FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV... Dec 28, 2023 FDA drug enforcement
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I Reported ongoing
Distribution: Nationwide within the United States
Official source for FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV... Dec 28, 2023 FDA drug enforcement
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I Reported ongoing
Distribution: Nationwide within the United States
Official source for PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use o... Dec 28, 2023 FDA drug enforcement
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I Reported ongoing
Distribution: Nationwide within the United States
Official source for PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use ... Dec 28, 2023 FDA drug enforcement
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I Reported ongoing
Distribution: Nationwide within the United States
Official source for VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only;... Dec 28, 2023 FDA drug enforcement
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I Reported ongoing
Distribution: Nationwide within the United States
Official source for VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; ... Oct 4, 2023 FDA drug enforcement
Labeling: Not Elsewhere Classified
Class III Reported terminated
Distribution: USA Nationwide
Official source for Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx o... Oct 4, 2023 FDA drug enforcement
Labeling: Not Elsewhere Classified
Class III Reported terminated
Distribution: USA Nationwide
Official source for VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compoundi... Oct 4, 2023 FDA drug enforcement
Labeling: Not Elsewhere Classified
Class III Reported terminated
Distribution: USA Nationwide
Official source for VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compoundin... Feb 21, 2023 FDA drug enforcement
CGMP DEVIATIONS
Class II Reported terminated
Distribution: Nationwide within the United States including VA or other Government facilities
Official source for Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd... Feb 21, 2023 FDA drug enforcement
CGMP DEVIATIONS
Class II Reported terminated
Distribution: Nationwide within the United States including VA or other Government facilities
Official source for Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd E... Feb 21, 2023 FDA drug enforcement
CGMP DEVIATIONS
Class II Reported terminated
Distribution: Nationwide within the United States including VA or other Government facilities
Official source for Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compound...
Reasons in these listed records Lack of Assurance of Sterility: Leaking/damaged syringes. Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination. Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. Labeling: Not Elsewhere Classified These examples come from this result page and are not a ranking of every recall reason.
Checking Denver Solutions, LLC DBA Leiters Health Is there a recall on denver solutions, llc dba leiters health right now? This archive contains 22 records, including 14 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.