Leiter's Compounding Recall: Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.
Leiter's Compounding Recall: Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2. is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Leiter's Compounding; Product: Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution)
| Recalling firm | Leiter's Compounding |
|---|---|
| Product | Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), in a) 1 mL Total Volume (NDC 70360-017-38) and b) 10 mL Total Volume (NDC 70360-017-39) in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-017-38 |
| Reason for recall | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Nationwide |
| Recall initiated | 20160920 |
| Recall number | D-0013-2017 |
| Category | drug |
| State | CA |
| Country | United States |
$29/mo
Try RecallGuard →