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Recall archive

95,461 stored notices, from Jun 20, 2012 to Nov 18, 2026.

6 recalls · page 1 of 1

Drugs

Reported Feb 2, 2022

ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV bag, Rx Only, Edge…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Edge Pharma, LLC

Matched: Brand · Product · Product details — Lack of Assurance of Sterility

55 more products in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Apr 28, 2021

Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT)…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Edge Pharma, LLC

Matched: Brand · Product details — Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility

FDA (openFDA drug enforcement)

Drugs

Reported Mar 24, 2021

Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Edge Pharma, LLC

Matched: Brand · Product · Product details — Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage…

1 more product in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Jan 27, 2021

Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml (22.5mg/ml) 0.5ml per syringe.…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Edge Pharma, LLC

Matched: Brand · Product details — Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.

FDA (openFDA drug enforcement)

Drugs

Reported Jan 20, 2021

Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Rx Only,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Edge Pharma, LLC

Matched: Brand · Product details — Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.

FDA (openFDA drug enforcement)

Drugs

Reported Sep 16, 2020

Vancomycin HCL 1.5 mg Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 NDC 05446-1458-01

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Edge Pharma, LLC

Matched: Brand · Product · Product details — Labeling: Label Error on Declared Strength

FDA (openFDA drug enforcement)

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