Flurbiprofen Sodium Solution/ Drops Recall
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Questions & Answers
Side Effects & Adverse Reactions
With nonsteroidal anti-inflammatory drugs, there exists the potential for increased bleeding due to interference with thrombocyte aggregation. There have been reports that flurbiprofen sodium ophthalmic solution may cause increased bleeding of ocular tissues in conjunction with ocular surgery.
There exists the potential for cross-sensitivity to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Flurbiprofen sodium ophthalmic solution is indicated for the inhibition of intraoperative miosis.
There is currently no drug history available for this drug.
Flurbiprofen Sodium Ophthalmic Solution USP, 0.03% is a sterile topical nonsteroidal anti-inflammatory product for ophthalmic use. Flurbiprofen sodium is represented by the following structural formula:
C15H12 FNaO2 •2H2O
Mol. Wt. 302.27
Chemical Name: Sodium (±)-2-(2-fluoro-4-biphenyl)-propionate dihydrate.
Each mL Contains: ACTIVE: Flurbiprofen sodium 0.03%;
INACTIVES: Sodium Citrate, Polyvinyl Alcohol 1.4%, Edetate Disodium, Potassium Chloride, Sodium Chloride, Citric Acid, Purified Water. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (6.0 – 7.0).
PRESERVATIVE ADDED: Thimerosal 0.005%.