FDAFDA · Food and drugs·Recall number D-1496-2022
Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478-622-35
Published September 14, 2022 · Recall initiated: August 31, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Akorn, Inc.
- Distributor
- USA nationwide
- Lot
- Lot#: 9J58A, 9J58B, Exp 8/31/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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