FDA Drug recall D-0013-2017
Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), in a) 1 mL Total Volu…
- FDA Drug
- Class II
- terminated
- Published 2016-10-19
On 2016-10-19 the FDA classified a Class II recall of Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), in a) 1 mL Total Volu… by Leiter S Compounding, citing lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0013-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-09-20 |
| Published | 2016-10-19 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Leiter S Compounding |
| Distribution | US |
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
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Identifiers
| code_info | All unexpired lots; a) Expirations dates of 10/03/2016 to 11/06/2016 and b) 09/25/2016 to 10/01/2016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0013-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.