Phenylephrine 2 — Class II drug recall D-0687-2017
Terminated recall by Isomeric Pharmacy Solution, LLC, reported 2017-05-03, distributed nationwide. Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of pro
| Recall number | D-0687-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Isomeric Pharmacy Solution, LLC, Salt Lake City, UT, United States |
| Recall initiated | 2017-04-06 |
| Classified | 2017-04-26 |
| Reported by FDA | 2017-05-03 |
| Terminated | 2017-08-30 |
| Distributed | Nationwide (US) |
| Quantity | 5,165 bottles |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00370285130014 |
| Lot numbers | 10003, 10018, 10023, 10025, 10027, 11011, 11012, 11024, 11026, 11029, 11030, 11032, 11045, 12008, 12014, 12015, 12022, 12024, 13001, 13002, 13011, 13012 |
| Model numbers | 1300 |
| Expiration dates | 2017-04-05, 2017-04-17, 2017-04-23, 2017-04-24, 2017-04-29, 2017-05-07, 2017-05-14, 2017-05-16, 2017-05-17, 2017-05-21, 2017-06-04, 2017-06-13, 2017-06-20, 2017-06-28, 2017-07-03, 2017-07-09 |
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 for recall
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0687-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.