Azasite Recall

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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.


AzaSite® is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following microorganisms:

CDC coryneform group G1

Haemophilus influenzae
Staphylococcus aureus
Streptococcus mitis group
Streptococcus pneumoniae

Efficacy for this organism was studied in fewer than 10 infections.


There is currently no drug history available for this drug.

Other Information

AzaSite (azithromycin ophthalmic solution) is a 1% sterile aqueous topical ophthalmic solution of azithromycin formulated in DuraSite® (polycarbophil, edetate disodium, sodium chloride). AzaSite is an off-white, viscous liquid with an osmolality of approximately 290 mOsm/kg.

Preservative: 0.003% benzalkonium chloride. Inactives: mannitol, citric acid, sodium citrate, poloxamer 407, polycarbophil, edetate disodium (EDTA), sodium chloride, water for injection, and sodium hydroxide to adjust pH to 6.3.

Azithromycin is a macrolide antibiotic with a 15-membered ring. Its chemical name is (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-aza-cyclopentadecan-15-one, and the structural formula is:

image of azithromycin chemical structure

Azithromycin has a molecular weight of 749, and its empirical formula is C38H72N2O12.

Azasite Manufacturers

  • Inspire Pharmaceuticals, Inc.
    Azasite (Azithromycin) Solution [Inspire Pharmaceuticals, Inc.]
  • Akorn, Inc.
    Azasite (Azithromycin Monohydrate) Solution/ Drops [Akorn, Inc.]

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