FDA Recall
Terminated
Historical recordClass II
1 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 ml in 100 ml Hospira LifeCare Bag, Service Code 2H8919, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-0919-52
by PharMEDium Services, LLC
- Reason
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
1 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9998, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-998-95
by PharMEDium Services, LLC
- Reason
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
1 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9232, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-032-95
by PharMEDium Services, LLC
- Reason
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
1 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassettes, Service Code 2T8175 Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-175-48
by PharMEDium Services, LLC
- Reason
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.5% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2N1488 (NDC 61553-488-11), 500 mL in 500 mL Baxter Intravia Bag, Service Code 2N1489 (NDC 61553-489-01)Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
by PharMEDium Services, LLC
- Reason
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by PharMEDium Services, LLC
- Reason
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.4 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8577, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-577-50
by PharMEDium Services, LLC
- Reason
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.4 mcg/mL Sufentanil Citrate and 0.0625% Bupivacaine HCl (Preservative Free), 150 mL in 150 mL Baxter Intravia Bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-713-95
by PharMEDium Services, LLC
- Reason
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; , Service Code 2H8120 , NDC 61553-120-50 , 250 ml in 250 ml Hospira LifeCare Bag ; , Service Code 2H8243 , NDC 61553-243-54 , 200 ml in 250 ml Hospira LifeCare Bag ; , Service Code 2K8120 , NDC 61553-120-09 , 400 ml in 500 ml Baxter Intravia Bag ; , Service Code 2K8243 , NDC 61553-243-37 , 200 ml in 250 ml Baxter Intravia Bag ; , Service Code 2K9120 , NDC 61553-120-03 , 500 ml in 500 ml Baxter Intravia Bag ; , Service Code 2N1120 , NDC 61553-120-84 , 400 ml in 500 ml Baxter Intravia Bag ; , Service Code 2N9619 , NDC 61553-619-97 , 250 ml in 250 ml Baxter Intravia Bag ; Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
by PharMEDium Services, LLC
- Reason
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 400 mL in 500 mL Baxter Intravia Bag , Service Code 2K8119 (NDC 61553-119-09), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8171(NDC 61553-171-37)150 mL in 150 mL Baxter Intravia Bag, Service Code 2K8463 (NDC 61553-463-47), 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2K8931(NDC 61553-931-02), 400 ml in 500 mL Baxter Intravia Bag, Service Code 2N1119, (NDC 61553-119-84), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, ;
by PharMEDium Services, LLC
- Reason
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2T8217, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-217-50
by PharMEDium Services, LLC
- Reason
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag Service Code 2H8194 (NDC 61553-194-52 ), 250 mL in 250 mL Cormix Bag ,Service Code 2C8192 (NDC 61553-192-17), 400 mL in 500 mL Baxter Intravia Bag, Service Code 2K8169 (NDC 61553-169-01), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
by PharMEDium Services, LLC
- Reason
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, Service Code 2K8195, 100 ml in 150 ml Baxter Intravia Bag (NDC 61553-195-48), Service Code 2H8266, 250 ml in 250 ml Hospira LifeCare Bag NDC 61553-266-50), 100 ml in 100 ml Hospira LifeCare Bag, Service Code 2H8272(NDC 61553-272-52), 100 ml in 100 ml Yellow Smiths Medical Cassette Service Code 2K8941 (NDC 61553-941-48), 250 ml in 250 ml Baxter Intravia Bag (W/O Additive Cap) Service Code 3V8716, (NDC 61553-716-17), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141,
by PharMEDium Services, LLC
- Reason
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.1 mg/mL Morphine Sulfate and 0.05% Bupivacaine HCI (Preservative Free) in 0.9%, 150 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9994 , Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-994-83
by PharMEDium Services, LLC
- Reason
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, a) 250 mL Hospira LifeCare Bag (NDC 61553-197-50), b) 250 mL Hospira LifeCare Bag (NDC 61553-197-50), c) 150 mL Baxter Intravia Bag (NDC 61553-189-48), d) 250 mL Baxter VIAFLEX Bag ( NDC 61553-197-02), e) 250 mL White Smiths Medical Cassette (NDC 615530-933-11) f) 250 mL Yellow Smiths Medical Cassette (NDC 61553-190-50), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 ;
by PharMEDium Services, LLC
- Reason
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.05 mg/mL Morphine Sulfate and 0.0625% Bupivacaine HCI (Preservative Free) in 0.9% Sodium Chloride, 250 mL Hospira LifeCare bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-995-54 ,
by PharMEDium Services, LLC
- Reason
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.03% Bupivacaine HCl (Preservative Free) in Sodium Chloride 0.9%, 250 mL Medical Cassette Reservoir, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-931-11
by PharMEDium Services, LLC
- Reason
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Atkins Nutritionals, Inc.
- Product
- Day Break Chocolate Hazelnut Bar 6x5, UPC: 637480055321, Cas…
- Reason
- Atkins Nutritionals is recalling certain bar products because they contain or may have come in contact with equipment that processed product containing sunflower seeds distributed by supplier SunOpta Inc. that have the potential to be contaminated with Listeria monocytogenes.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Wm Bolthouse Farms Inc
- Product
- Bolthouse Farms Chocolate Protein Plus: 22 g protein per bo…
- Reason
- Bolthouse Farms is recalling 8 varieties of Protein Plus and Perfectly Protein drinks due to spoilage that may cause beverage to appear lumpy and have an unpleasant taste and odor.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Kellogg Company
- Product
- Kashi Whole Grain Trail Mix Bars 35 g individual bar, 6 co…
- Reason
- Product contains sunflower seeds potentially contaminated with Listeria monocytogenes. Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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