NORepinephrine 4 mg in 250 mL Sodium Chloride0 — Class II drug recall D-1587-2014
Terminated recall by Unique Pharmaceutical, Ltd, reported 2014-09-24, distributed in PA, TN, TX. Lack of Assurance of Sterility: A mold like substance was discovered on the surface of an unopened bag of Sodi
| Recall number | D-1587-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Unique Pharmaceutical, Ltd, Temple, TX, United States |
| Recall initiated | 2013-04-17 |
| Classified | 2014-09-16 |
| Reported by FDA | 2014-09-24 |
| Terminated | 2016-01-26 |
| Distributed | PA, TN, TX |
| Quantity | 430 bags |
| Reason classes | microbial contamination, sterility |
| Pathogens | mold |
| Lot numbers | 00083844, 07/13 |
Product
NORepinephrine 4 mg in 250 mL Sodium Chloride0.9%, For IV Use Only, Flexible Bag, Rx only, UNIQUE PHARMACEUTICALS, Inc.Temple, TX USA 76502
Reason for recall
Lack of Assurance of Sterility: A mold like substance was discovered on the surface of an unopened bag of Sodium Chloride 0.9% while prepping the bag for production.
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-1587-2014. 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.