Home / Recalls / Pharmedium Services, LLC / D-1428-2015

D-1428-2015 Class II Terminated

Recalled by Pharmedium Services, LLC — Lake Forest, IL

FDA drug recall D-1428-2015 was initiated by Pharmedium Services, LLC on Jul 21, 2015 and is designated Class II. 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. The recall status is terminated (terminated Sep 11, 2015). Affected quantity: 120 cassettes.

Recall Details

Product Type: Drugs
Report Date: Sep 16, 2015
Initiation Date: Jul 21, 2015
Termination Date: Sep 11, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 120 cassettes

Product Description

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.

Distribution Pattern

VA, IL, PA, ID

Code Information

Lot #: 151900249M, Exp 09/09/15

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1428-2015
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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