March 04, 2020
A half-dozen lots of ophthalmic ointment are being recalled by Akorn Inc. after reports of brown spots on the inside of product tubes. According to the March 4, 2020, US Food and Drug Administration (FDA) Enforcement Report, the spots were identified as tin with trace copper, which are the base of materials used to manufacture the tubes.
The recall affects the following products, which were distributed within the United States and Puerto Rico:
- sodium chloride ophthalmic ointment, 5%, 3.5-g tubes (NDC 17478-622-35), from lots 8B66A (Exp. 1/21), 8C91A (Exp. 2/21), 8F07A and 8F16A (Exp. 5/21), and 8F13A (Exp. 7/21);
- Well at Walgreens sodium chloride ophthalmic ointment, 5%, 3.5-g tubes (NDC 0363-9050-00), distributed by Walgreen Co., from lot 8G59A (Exp. 6/21); and
- CVS Health sodium chloride ophthalmic ointment, 5%, 3.5-g tubes (NDC 59779-303-01), distributed by CVS Pharmacy Inc., from lot 8G50A (Exp. 6/21).
Akorn voluntarily initiated the recall February 21, 2020. On February 27, 2020, the FDA designated the recall Class III. The classification suggests use of the affected products is not likely to cause adverse health consequences.
Sodium chloride ophthalmic ointment is an over-the-counter medication used to reduce cornea swelling in patients with certain eye conditions.