Class II · Moderate risk
Tropicamide Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Well at Walgreens Sodium Chloride Ophthalmic Ointment USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
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.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed by: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-9050-00.
Affected NDC
0363-9050-00
Compare with the code on your package — it is the most precise check available.
Category: Eye Drops & Ophthalmic
- Recalling firm
- Akorn, Inc.
- NDC code
- 0363-9050-00
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0860-2020 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. 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 2020 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 particulate / foreign matter recalls from 2020
All particulate / foreign matter recalls
Class I · High risk
Ketorolac Tromethamine Injection
Presence of Particulate Matter - found in reserve sample vials at the firm.
Class III · Low risk
Oxycodone Hydrochloride Oral Solution
Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
Class II · Moderate risk
Ketorolac Tromethamine Injection
Presence of Particulate Matter - found in reserve sample vials at the firm.
Class II · Moderate risk
Levetiracetam Tablets
Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets.
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