Recall archive
54 recalls · page 3 of 3
Reported Apr 29, 2015
Fluorescein Sodium Ophthalmic Strips USP, 0.6 mg per strip, labeled as 1) Fluorescein GloStrips, individually wrapped…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Nomax Inc.
Matched: Product details — Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to…
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Mar 11, 2015
Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with net fill weight of 16 g that…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Akorn, Inc.
Matched: Brand · Product details — Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.
FDA (openFDA drug enforcement)
Reported Feb 18, 2015
Erythromycin Pledgets USP, 2%, 60-count jar,Rx only, Manufactured by Ei LLC, Kannapolis, NC 28083, Marketed by…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Akorn, Inc.
Matched: Brand — Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests.
FDA (openFDA drug enforcement)
Reported Jan 14, 2015
Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60).
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Akorn, Inc.
Matched: Brand — Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point.
FDA (openFDA drug enforcement)
Reported Oct 1, 2014
Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx only For IV Infusion only,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Akorn, Inc.
Matched: Brand · Product details — Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point
FDA (openFDA drug enforcement)
Reported Nov 21, 2012
Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only, Sterile, Mfg By Akorn, Inc., Lake…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Stat Rx USA
Matched: Product · Product details — Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."
1 more product in this recall
FDA (openFDA drug enforcement)
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