FDA (Drugs) recall action 74057

Pharmedium Services, LLC recalled 75 products on 2016-07-27

The FDA (Drugs) publishes a recall like this one as 75 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 75 pages.

Products: 75
Announced: 2016-07-27
Critical: 0
Units: 227,975

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–25 of 75

SevereFDA (Drugs)··2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate
PharMEDium Services is recalling 1,470 bags of compounded fentanyl and bupivacaine injectable solutions nationwide due to the presence of glass particulate matter.
Product
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 Intr
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0 states
SevereFDA (Drugs)··2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Infusions Due to Glass Particulates
PharMEDium Services, LLC is recalling 21 cassettes of compounded fentanyl and bupivacaine infusions because the active ingredient was contaminated with glass particulate matter.
Product
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 61
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SevereFDA (Drugs)··2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate
PharMEDium Services, LLC is recalling 480 bags of compounded fentanyl and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.
Product
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
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0 states
SevereFDA (Drugs)··2016-07-27
PharMEDium Recalls Sterile Injectable Drugs Contaminated with Glass Particulate Matter
PharMEDium Services is recalling 30 bags of sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of glass particulate matter.
Product
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
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0 states
SevereFDA (Drugs)··2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates
PharMEDium Services is recalling 10 bags of compounded fentanyl and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.
Product
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
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SevereFDA (Drugs)··2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulates
PharMEDium Services, LLC is recalling 230 syringes of compounded Fentanyl Citrate and Bupivacaine HCl because the active ingredient was contaminated with glass particulate matter.
Product
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
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0 states
SevereFDA (Drugs)··2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulate
PharMEDium Services, LLC is recalling 79 syringes of compounded Fentanyl Citrate and Bupivacaine HCl due to the presence of glass particulate matter in the active pharmaceutical ingredient.
Product
6.66 mcg/mL Fentanyl Citrate and 0.22% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 15 mL in 20 mL BD Syringe, Service Code 2T6156, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-156-86
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0 states
SevereFDA (Drugs)··2016-07-27
PharMEDium Recalls Sufentanil and Bupivacaine Bags Due to Glass Particulate
PharMEDium Services, LLC is recalling 25 bags of compounded Sufentanil and Bupivacaine injectable solution because the active ingredient was contaminated with glass particulate.
Product
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
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0 states
SevereFDA (Drugs)··2016-07-27
PharMEDium Recalls Hydrocodone and Bupivacaine Syringes Due to Glass Particulates
PharMEDium Services, LLC is recalling 1,577 syringes of compounded hydrocodone and bupivacaine injectable drugs nationwide due to the presence of glass particulate matter.
Product
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
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SevereFDA (Drugs)··2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates
PharMEDium Services is recalling 90 bags of compounded fentanyl and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.
Product
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
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0 states
SevereFDA (Drugs)··2016-07-27
Pharmedium Recalls Hydrocodone and Bupivacaine Syringes Due to Glass Particulates
Pharmedium Services is recalling 435 syringes of compounded hydrocodone and bupivacaine due to glass particulate contamination.
Product
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
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0 states
SevereFDA (Drugs)··2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates
PharMEDium Services is recalling 345 bags of compounded fentanyl and bupivacaine injectable solutions nationwide due to the presence of glass particulate matter.
Product
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 Baxte
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0 states
SevereFDA (Drugs)··2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates
PharMEDium Services is recalling 380 bags of compounded fentanyl and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.
Product
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
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SevereFDA (Drugs)··2016-07-27
PharMEDium Recalls Bupivacaine HCl Due to Glass Particulate Contamination
PharMEDium Services, LLC is recalling 355 bags of 0.2% Bupivacaine HCl sterile injectable drugs because the active ingredient was contaminated with glass particulate matter.
Product
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 (
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SevereFDA (Drugs)··2016-07-27
PharMEDium Recalls Sterile Injectable Drugs Contaminated with Glass Particulate Matter
PharMEDium Services, LLC is recalling 115 bags of compounded sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of glass particulate matter.
Product
5 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8483, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-483-61
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0 states
SevereFDA (Drugs)··2016-07-27
PharMEDium Recalls Morphine and Bupivacaine Bags Due to Glass Particulate
PharMEDium Services is recalling 80 bags of compounded morphine and bupivacaine injectable solution due to the presence of glass particulate matter.
Product
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 ,
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SevereFDA (Drugs)··2016-07-27
PharMEDium Recalls Sufentanil and Bupivacaine Cassettes Due to Glass Particulates
PharMEDium Services is recalling 325 cassettes of compounded sufentanil and bupivacaine because the active ingredient was contaminated with glass particulate matter.
Product
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
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SevereFDA (Drugs)··2016-07-27
PharMEDium Recalls Sterile Injectable Drugs Contaminated with Glass Particulate
PharMEDium Services, LLC is recalling 1,234 cassettes of sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of glass particulate matter.
Product
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 61553-909-0
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SevereFDA (Drugs)··2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Cassettes Due to Glass Particulate
Pharmedium Services is recalling 5,727 sterile injectable cassettes containing fentanyl and bupivacaine because they were produced using an active pharmaceutical ingredient contaminated with glass particulate.
Product
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 Co
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SevereFDA (Drugs)··2016-07-27
PharMEDium Recalls Sterile Injectable Drugs Contaminated with Glass Particulate
PharMEDium Services, LLC is recalling 445 bags of sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of glass particulate matter.
Product
5 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 2H8477 (NDC 61553-477-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8477 (NDC 61553-477-61), Rx Only, Compounded by
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SevereFDA (Drugs)··2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate
Pharmedium Services, LLC is recalling 43,589 bags of sterile injectable fentanyl and bupivacaine because the active ingredient was contaminated with glass particulate matter.
Product
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
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SevereFDA (Drugs)··2016-07-27
FDA Recalls Fentanyl and Bupivacaine Injectable Bags Due to Glass Particulates
Pharmedium Services is recalling 97,716 bags of sterile injectable fentanyl and bupivacaine because they were produced using an active pharmaceutical ingredient contaminated with glass particulate matter.
Product
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
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SevereFDA (Drugs)··2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Cassettes Due to Glass Particulates
Pharmedium Services is recalling 2,256 cassettes of compounded Fentanyl and Bupivacaine because glass particulates were found in the active ingredient.
Product
5 mcg/mL Fentanyl Citrate and 0.04% 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 2K8809, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-80
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SevereFDA (Drugs)··2016-07-27
FDA Recalls Hydrocodone and Bupivacaine Syringes Due to Glass Particulates
PharMEDium Services is recalling 5 syringes of compounded hydrocodone and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.
Product
5 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6197, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-197-20
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SevereFDA (Drugs)··2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Cassettes Due to Glass Particulate
Pharmedium Services, LLC is recalling 936 cassettes of compounded Fentanyl Citrate and Bupivacaine HCl due to the presence of glass particulate matter in the sterile injectable solution.
Product
4 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, flow stop, free-flow protection, Service Code 2T8214, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 6155
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