Ropivacaine HCl 0 — Class II drug recall D-1428-2015
Terminated recall by Pharmedium Services, LLC, reported 2015-09-16, distributed in ID, IL, PA, VA. Lack of Assurance of Sterility: The firm received a complaint of a sterility failure using a non-validated ste
| Recall number | D-1428-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pharmedium Services, LLC, Lake Forest, IL, United States |
| Recall initiated | 2015-07-21 |
| Classified | 2015-09-10 |
| Reported by FDA | 2015-09-16 |
| Terminated | 2015-09-11 |
| Distributed | ID, IL, PA, VA |
| Quantity | 120 cassettes |
| Reason classes | sterility |
| NDC | 61553-0834-48 |
| Lot numbers | 151900249M |
| Expiration dates | 2015-09-09 |
Product
Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res. Flowstop in Sodium Chloride 0.9%, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-834-48
Reason for recall
Lack of Assurance of Sterility: The firm received a complaint of a sterility failure using a non-validated sterility test on a medication cassette.
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-1428-2015. 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.