Home / Recalls / Pharmedium Services, LLC / D-1411-2016

D-1411-2016 Class II Terminated

Recalled by Pharmedium Services, LLC — Lake Forest, IL

FDA drug recall D-1411-2016 was initiated by Pharmedium Services, LLC on May 5, 2016 and is designated Class II. Reason for recall: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. The recall status is terminated (terminated Mar 6, 2018). Affected quantity: 212 Medical Cassettes.

Recall Details

Product Type: Drugs
Report Date: Jul 27, 2016
Initiation Date: May 5, 2016
Termination Date: Mar 6, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 212 Medical Cassettes

Product Description

20 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 ml in 100 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2T8216, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-216-96

Reason for Recall

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Distribution Pattern

Nationwide

Code Information

Lot Number 160600315M , Exp. Date 5/7/2016 ; Lot Number 160670256M , Exp. Date 5/14/2016 ; Lot Number 160730057M , Exp. Date 5/20/2016 ; Lot Number 160740144M , Exp. Date 5/20/2016 ; Lot Number 160800152M , Exp. Date 5/27/2016 ; Lot Number 160900142M , Exp. Date 6/5/2016 ; Lot Number 160910123M , Exp. Date 6/6/2016 ; Lot Number 160940037M , Exp. Date 6/9/2016 ; Lot Number 161080048M , Exp. Date 6/24/2016 ;

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1411-2016
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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