Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/… — Class II drug recall D-0685-2017
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-0685-2017 |
|---|---|
| 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 | 851 vials |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00370285110139 |
| Lot numbers | 09003, 11003, 11035, 11039, 12002, 12012 |
| Model numbers | 1101 |
| Expiration dates | 2017-04-17, 2017-06-21, 2017-07-03, 2017-07-05, 2017-07-23, 2017-07-30 |
Product
Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1101, barcode 3 70285 11013 9.
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-0685-2017. 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.