Drug recall
Ciprofloxacin Ophthalmic Solution, USP, 0.3%, ciprofloxacin hydrochloride 3.5 mg equivalent to 3 mg base; Rx…
FDA recall event 30856 · Class II · Apotex Corp.
Key facts
| Event ID | 30856 |
|---|---|
| Recall numbers | D-120-5 |
| Recalling firm | Apotex Corp. |
| Product type | Drugs |
| Products | Ciprofloxacin Ophthalmic Solution, USP, 0.3%, ciprofloxacin hydrochloride 3.5 mg equivalent to 3 mg base; Rx only, sterile ophthalmic solution for topical ophthalmic use only in 5 mL plastic dispenser… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Impurities/Degradation Products: Degradation Products: Degradation level exceeds specification requirement of less than 0.2% impurities. |
| Initiation date | Jan 19, 2005 |
| City | Lincolnshire |
| Country | United States |
| FEI number | 3001576563 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports