Class II
Terminated
0.5 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2T8317, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-317-52
- Company
- Pharmedium Services, Llc
- Recall Initiated
- May 5, 2016
- Posted
- July 27, 2016
- Recall Number
- D-1371-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 325 Medical Cassettes
- Firm Location
- Lake Forest, IL, United States
Reason for Recall
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Distribution
Nationwide
Lot / Code Info
Lot Number 160960175M; Exp. Date 5/6/2016 Lot Number 160970036M; Exp. Date 5/7/2016 Lot Number 161080071M; Exp. Date 5/18/2016
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