Class II · Moderate risk Ongoing
Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc…
Reason Failed Impurities/Degradation Specifications
Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b)…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Failed preservative effectiveness testing
What was recalled
Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-04), Rx Only, Mfg for: Apotex Corp., Weston, FL 33326.
- Recalling firm
- Apotex Inc.
- NDC code
- 60505-0595-05
- Origin
- N/A, Canada
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0009-2016
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Bromfenac recalls
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Class II · Moderate risk Ongoing
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compounded by…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis…
Reason Subpotent Drug
Class III · Low risk Terminated
Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B…
Reason Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
Class II · Moderate risk Terminated
BROMFENAC OPHTHALMIC SOLUTION 0.09% 1.7ML NDC/UPC 62332-508-17; RX; DROPS
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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