Class II · Moderate risk
Tropicamide Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Sodium Chloride Ophthalmic Ointment USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was 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.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What 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
Affected NDC
17478-0622-35
Compare with the code on your package — it is the most precise check available.
Category: Eye Drops & Ophthalmic
- Recalling firm
- Akorn, Inc.
- NDC code
- 17478-622-35
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1496-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Akorn, Inc.
All 2022 recalls
Class II · Moderate risk
Ropivacaine Hydrochloride Injection USP
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Pilocarpine Hydrochloride Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Pilocarpine Hydrochloride Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Other sterility / contamination recalls from 2022
All sterility / contamination recalls
Class II · Moderate risk
TriMix Injection
Lack of Assurance of Sterility
Class II · Moderate risk
BiMix STD 001
Lack of Assurance of Sterility
Class II · Moderate risk
QuadMix Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix Plus 002
Lack of Assurance of Sterility
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