FDAFebruary 21, 2020drug
CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed By: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895, NDC 59779-303-01
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.
What to do
FDA enforcement status: Terminated
Brands named
akorn
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAArtificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs2023-04-26
- FDACalcipotriene Topical Solution, 0.005% (Scalp Solution), 60 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs2023-04-26
- FDAArtificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs2023-04-26
- FDAAzelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, For Intranasal Use Only, Manufactured by: Hi-Tech Pharmacal Co., INC., Amityville, NY 11701. ALL NDCs2023-04-26
- FDAKetorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged in a) 3mL bottles, b bottles) 5 mL, and c)10 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs2023-04-26
- FDALidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs2023-04-26
- FDAClobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs2023-04-26
- FDAClobetasol Propionate Cream, USP, 0.05%, packaged in a) 15g tubes, b) 30g tubes, and c) 60g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs2023-04-26
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