FDA Drug recall D-1428-2015
Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res
- FDA Drug
- Class II
- terminated
- Published 2015-09-16
On 2015-09-16 the FDA classified a Class II recall of Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res by Pharmedium Services, citing lack of Assurance of Sterility: The firm received a complaint of a sterility failure using a non-validated sterility test on a medication cassette.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1428-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-21 |
| Published | 2015-09-16 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Pharmedium Services |
| Distribution | ID, IL, PA, VA |
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
Lack of Assurance of Sterility: The firm received a complaint of a sterility failure using a non-validated sterility test on a medication cassette.
Identifiers
| code_info | Lot #: 151900249M, Exp 09/09/15 |
|---|
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-1428-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.