Products Affected - Description

• • Ofloxacin ophthalmic solution, Rising Pharmaceuticals, 5 mL bottle, 1 count, NDC 64980-0515-05

Reason for the Shortage

• • AbbVie has Ocuflox available.
  • Akorn ceased operations in February 2023.
  • Apotex has ofloxacin ophthalmic solution available.
  • Bausch Health has ofloxacin ophthalmic solution available.
  • Rising did not provide a reason for the shortage.
  • Sandoz discontinued ofloxacin ophthalmic solution.

Available Products

• • Ocuflox ophthalmic solution, Allergan (AbbVie), 5 mL bottle, 1 count, NDC 11980-0779-05
  • Ofloxacin ophthalmic solution, Apotex, 10 mL bottle, 1 count, NDC 60505-0560-01
  • Ofloxacin ophthalmic solution, Apotex, 5 mL bottle, 1 count, NDC 60505-0560-00
  • Ofloxacin ophthalmic solution, Bausch Health, 10 mL bottle, 1 count, NDC 24208-0434-10
  • Ofloxacin ophthalmic solution, Bausch Health, 5 mL bottle, 1 count, NDC 24208-0434-05
  • Ofloxacin ophthalmic solution, Rising Pharmaceuticals, 10 mL bottle, 1 count, NDC 64980-0515-01

• • Rising has ofloxacin ophthalmic solution in 5 mL bottles on back order and the company cannot estimate a release date.

• • Ofloxacin ophthalmic solution is a fluorinated carboxyquinolone antibiotic used to treat bacterial conjunctivitis and corneal ulcers in pediatric and adult patients.[1]

• • The American Academy of Ophthalmology (AAO) recommends selecting the least expensive broad-spectrum ophthalmic antibiotic for a 5-7 day treatment strategy for bacterial conjunctivitis. No clinical evidence supports any antibiotic over another.[2]
  • For corneal ulcers (bacterial keratitis), AAO recommends an ophthalmic fluoroquinolone (ciprofloxacin 0.3%, ofloxacin 0.3%, and levofloxacin 1.5%) as empiric treatment to cover most bacteria.[3]

• 1. DailyMed - Ofloxacin ophthalmic solution. Accessed July 17, 2024. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fe564e33-8f5d-4b57-87a9-7afae02eaf97.
  2. Cheung AY, Choi DS, Ahmad S, et al. Conjunctivitis Preferred Practice Pattern. Ophthalmology. 2024;131(4):P134-P204. doi:10.1016/j.ophtha.2023.12.0373.
  3. Rhee MK, Ahmad S, Amescua G, et al. Bacterial Keratitis Preferred Practice Pattern®. Ophthalmology. 2024;131(4):P87-P133. doi:10.1016/j.ophtha.2023.12.035.