FDA Drug recall D-0687-2017
Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalmic) Drops in a bottle, Rx Only, Isomeric Pharmacy Solutions…
- FDA Drug
- Class II
- terminated
- Published 2017-05-03
On 2017-05-03 the FDA classified a Class II recall of Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalmic) Drops in a bottle, Rx Only, Isomeric Pharmacy Solutions… by Isomeric Pharmacy Solution, citing lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0687-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-06 |
| Published | 2017-05-03 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Isomeric Pharmacy Solution |
| Distribution | US |
Product
Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalmic) Drops in a bottle, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1300, barcode 3 70285 13001 4.
Reason
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Identifiers
| code_info | Lot Numbers: 10003, Exp 04/05/17; 10018, Exp 04/17/17; 10023, Exp 04/23/17; 10025, Exp 04/24/17; 10027, Exp 04/29/17; 1…Lot Numbers: 10003, Exp 04/05/17; 10018, Exp 04/17/17; 10023, Exp 04/23/17; 10025, Exp 04/24/17; 10027, Exp 04/29/17; 11011, 11012, Exp 05/07/17; 11024, 11026, Exp 05/14/17; 11029, Exp 05/16/17; 11030, Exp 05/17/17; 11032, Exp 05/21/17; 11045, Exp 06/04/17; 12008, Exp 06/13/17; 12014, 12015, Exp 06/20/17; 12022, 12024, Exp 06/28/17; 13001, 13002, Exp 07/03/17; 13011, 13012, Exp 07/09/17. |
|---|
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-0687-2017%22
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