Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) Supply Disruption — Mayne Pharma Usa (Moderate Ri
Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) Supply Disruption — Mayne Pharma Usa (Moderate Ri is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b); Manufacturer: Mayne
| Drug name | Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) |
|---|---|
| Manufacturer | Mayne Pharma Usa |
| Recall/Disruption reason | Lack of Assurance of Sterility: Failed preservative effectiveness test |
| Risk classification | Moderate Risk — Temporary Health Consequence |
| Status | Terminated |
| Record type | Enforcement/Recall |
| Recall number | D-0585-2016 |
| Initiation date | 20160105 |
| Quantity affected | a) 52034 bottles and b) 22074 bottles |
| Dosage form | Drugs |
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