FDA Recall
Terminated
Historical recordClass II
2 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; Service Code 2H8125 , NDC 61553-125-52 , 100 ml in 100 ml Hospira LifeCare Bag ; Service Code 2H8204 , NDC 61553-204-54 , 200 ml in 250 ml Hospira LifeCare Bag ; Service Code 2H8205 , NDC 61553-205-50 , 250 ml in 250 ml Hospira LifeCare Bag ; Service Code 2K8104 , NDC 61553-104-03 , 500 ml in 500 ml Baxter Intravia Bag ; Service Code 2K8124 , NDC 61553-124-48 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8204 , NDC 61553-204-37 , 200 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8205 , NDC 61553-205-02 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8443 , NDC 61553-443-47 , 150 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8491 , NDC 61553-491-30 , 125 ml in 150 ml Baxter Intravia Bag ; Service Code 2K9491 , NDC 61553-491-96 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K9802 , NDC 61553-802-96 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 4J8205 , NDC 61553-205-97 , 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
2 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Service Code 2C8201 , NDC 61553-201-58 , 200 ml in 250 ml Cormix Bag ; Service Code 2H8131 , NDC 61553-131-50 , 250 ml in 250 ml Hospira LifeCare Bag ; Service Code 2H8201 , NDC 61553-201-54 , 200 ml in 250 ml Hospira LifeCare Bag ; Service Code 2K8122 , NDC 61553-122-48 , 100 ml in 100 ml Baxter APII Bag ; Service Code 2K8123 , NDC 61553-123-48 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8131 , NDC 61553-131-02 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8201 , NDC 61553-201-37 , 200 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8442 , NDC 61553-442-30 , 125 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8490 , NDC 61553-490-47150 ml in 150 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
2 mcg/mL Fentanyl Citrate and 0.083% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8871(NDC 61553-871-48), 250 mL in 250 mL Yellow Smiths Medical Cassette, Service Code 2T8871 (NDC 61553-871-50), 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
2 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8296 (NDC 61553-296-52), 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8296 (NDC 61553-296-22), 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
2 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 130 mL in 150 mL Baxter Intravia Bag, Service Code, 2K9226 (NDC 61553-226-98), 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K9294 (NDC 61553-0294-92), 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
2 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9966, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-966-95
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
2 mcg/mL Fentanyl Citrate and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8095, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-095-50 ,
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
2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8103, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-103-48
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
16.67 mcg/mL Fentanyl Citrate and 0.1667% Bupivacaine HCl (Preservative Free), 1.5 mL in 3 mL BD Syringe, Service Code 2T6228, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-228-96
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
10 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8908, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-908-02 ,
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
10 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette (stop free-flow protection), Service Code 2K8909, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-909-02 ,
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
10 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8480, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-480-50
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
10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6733, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-733-20
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
10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-733-17
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
10 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 10 mL in 10 mL BD Syringe, Service Code 2T6203Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-203-27
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
10 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride;, 10 mL in 12 mL Monoject Syringe, Service Code 2T6014 (NDC 61553-014-20), 50 mL in 60 mL BD Syringe , Service Code 2T6636 (NDC 61553-636-27), 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
10 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8142, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-142-02
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
10 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H9155, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 3614, NDC 61553-1552-52
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
10 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 ml in 250 ml Hospira LifeCare Bag ,Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-143-50
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
1.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; Service Code 2T8232, (NDC 61553-232-97)250 ml in 250 ml Yellow Smiths Medical Cassette, flow stop free-flow protection Service Code 2T8878 100 ml in 100 ml Yellow Smiths Medical Cassette, flow stop free-flow protection ((NDC 61553-878-52), 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 →
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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