FDA Recall
Terminated
Historical recordClass II
3 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8837 (NDC 61553-837-48), Service Code 2K8906 (NDC 61553-906-48), Service Code 2K8963 (NDC 61553-963-48), Service Code 2K8976 (NDC 61553-976-48), 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
3 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8239 (NDC 61553-239-50), 250 mL in 250 Baxter Intravia Bag, Service Code 2K8239 (NDC 61553-239-02), 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K8284 (NDC 61553-284-01), 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
3 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8180 (NDC 61553-180-52), 250 mL in 250 mL Hospira LifeCare Bag Service Code 2H8262 (NDC 61553-262-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8180 (NDC 61553-180-02), 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
3 mcg/mL Fentanyl Citrate and 0.01% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K9217, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-217-97
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
20 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8947, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-947-48
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
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
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
20 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8494, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-494-61
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
20 mcg/mL HYDROmorphone HCl and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 55 mL in 60 mL Monoject Syringe, Service Code 2T6620, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-620-12
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
20 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8146, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-189-48
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
2.5 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8297, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-297-02
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
2.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Smiths Medical Cassette, flow stop free flow protection, Service Code 2K8972, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-0972-48
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
2.5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code K8255 (NDC 61553-255-37), 200 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8464 (NDC 61553-464-61), 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
2.5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8892, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-882-48
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
2.5 mcg/mL Fentanyl Citrate and 0.0312% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9195, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-195-50
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 100 mL Hospira LifeCare Bag, Service Code 2H8103 (NDC 61553-103-52), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8444 (NDC 61553-444-61), 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 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8108, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-108-02
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
2 mcg/mL Fentanyl Citrate and 0.167% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K9276, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-276-98
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 0.162% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free flow-flow protection, Service Code 2T8229, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-229-97
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 0.16% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8102, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-102-48
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
2 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K8433, NDC 61553-433-58, 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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