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
Reported: September 14, 2022 Initiated: August 31, 2022 #D-1496-2022
Product Description
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
Reason for Recall
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.
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- 48,636 tubes
- Distribution
- USA nationwide
- Location
- Gurnee, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Akorn, Inc.. Units affected: 48,636 tubes.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 14, 2022. Severity: Moderate. Recall number: D-1496-2022.
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