Class II · Moderate risk
Ofloxacin Ophthalmic Solution
CGMP Deviations:
Ofloxacin 0.3% 5ml Opth
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
OFLOXACIN 0.3% 5ML OPTH; NDC/UPC 17478071310; RX; DROPS
Drug: Ofloxacin
- Recalling firm
- Cardinal Health Inc.
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0408-2021 · 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 Ofloxacin recalls
See all
Class II · Moderate risk
Ofloxacin Otic Solution 0.3%
cGMP deviations: Temperature abuse
Class II · Moderate risk
Ofloxacin Ophthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Pre-Op Pledget Soln + Tetracaine
Lack of Assurance of Sterility
Class II · Moderate risk
Pre-Op Pledget Soln
Lack of Assurance of Sterility
Other recalls by Cardinal Health Inc.
All 2021 recalls
Class II · Moderate risk
Enoxaparin Sodium Injection
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Class II · Moderate risk
Recombinate
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
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