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, 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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SevereFDA (Drugs)··2016-07-27
FDA Recalls Hydrocodone and Bupivacaine Cassettes Due to Glass Particulates
Pharmedium Services is recalling 212 cassettes of compounded hydrocodone and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.
Product
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…
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SevereFDA (Drugs)··2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Infusions Due to Glass Particulates
PharMEDium Services is recalling specific lots of compounded fentanyl and bupivacaine infusions because they were produced using an active pharmaceutical ingredient contaminated with glass particulate matter.
Product
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
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SevereFDA (Drugs)··2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate
Pharmedium Services, LLC is recalling 562 bags of sterile injectable fentanyl and bupivacaine due to the presence of glass particulate matter.
Product
5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8287 (NDC 61553-287-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8287 (NDC 61553-287-02), 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 1,015 bags of compounded fentanyl and bupivacaine injectable solutions because the active ingredient was contaminated with glass particulate matter.
Product
3.5 mcg/mL Fentanyl Citrate and 0.0625%Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8470, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-470-30
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SevereFDA (Drugs)··2016-07-27
PharMEDium Recalls Sterile Injectable Drugs Contaminated with Glass Particulate Matter
PharMEDium Services, LLC is recalling 1,277 bags of sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of glass particulate matter.
Product
10 mcg/mL HYDROmorphone HCl and 0.125% 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 ,
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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 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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SevereFDA (Drugs)··2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulates
Pharmedium Services, LLC is recalling 3,927 syringes of compounded fentanyl and bupivacaine because glass particulates were found in the active pharmaceutical ingredient.
Product
5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL BD Syringe, Service Code 2T6140 (NDC 61553-140-20) , 60 mL in 60 mL BD Syringe, Service Code 2T6222 (NDC 61553-222-31), Rx Only, Compounded by PharMEDium Services…
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SevereFDA (Drugs)··2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Cassettes Due to Glass Particulate
Pharmedium Services, LLC is recalling 220 cassettes of compounded fentanyl and bupivacaine injectable drugs because the active ingredient was contaminated with glass particulate.
Product
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…
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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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SevereFDA (Drugs)··2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate
PharMEDium Services is recalling 655 bags of compounded fentanyl and bupivacaine injectable solutions because they were produced using an active pharmaceutical ingredient contaminated with glass particulate matter.
Product
5 mcg/mL Fentanyl Citrate and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8256, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-256-50 ,
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SevereFDA (Drugs)··2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate
PharMEDium Services is recalling 65 bags of compounded fentanyl and bupivacaine injectable solution because glass particulate was found in the active pharmaceutical ingredient.
Product
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
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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…
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SevereFDA (Drugs)··2016-07-27
PharMEDium Recalls Sufentanil and Bupivacaine Bags Due to Glass Particulates
PharMEDium Services is recalling 140 bags of compounded sufentanil and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.
Product
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
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SevereFDA (Drugs)··2016-07-27
FDA Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulate
PharMEDium Services is recalling 740 syringes of compounded fentanyl and bupivacaine because glass particulate was found in the active ingredient.
Product
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
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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…
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SevereFDA (Drugs)··2016-07-27
Pharmedium Recalls Hydrocodone and Bupivacaine Bags Due to Glass Particulate
Pharmedium Services is recalling 55 bags of compounded sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of glass particulate matter.
Product
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
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SevereFDA (Drugs)··2016-07-27
FDA Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulate Matter
PharMEDium Services is recalling 2,713 syringes of compounded fentanyl and bupivacaine because the active ingredient was contaminated with glass particulate matter.
Product
5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6257, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-257-20
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SevereFDA (Drugs)··2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates
PharMEDium Services is recalling 105 bags of compounded Fentanyl Citrate and Bupivacaine HCl sterile injectable drugs due to the presence of glass particulate matter.
Product
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
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SevereFDA (Drugs)··2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates
Pharmedium Services, LLC is recalling 95 bags of compounded fentanyl and bupivacaine injectable solutions nationwide because the active ingredient was contaminated with glass particulate matter.
Product
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…
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SevereFDA (Drugs)··2016-07-27
FDA Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate
PharMEDium Services is recalling 2,006 bags of compounded fentanyl and bupivacaine injectable drugs because the active ingredient was contaminated with glass particulate matter.
Product
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…
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SevereFDA (Drugs)··2016-07-27
PharMEDium Recalls Bupivacaine HCl Cassettes Due to Glass Particulate
PharMEDium Services, LLC is recalling 315 cassettes of 0.15% Bupivacaine HCl because the active ingredient was contaminated with glass particulate matter.
Product
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
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SevereFDA (Drugs)··2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate
PharMEDium Services is recalling 3,474 bags of sterile injectable fentanyl and bupivacaine because the active ingredient was contaminated with glass particulate.
Product
5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride Service Code 2K8135 , NDC 61553-135-48 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8136 , NDC 61553-136-02 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code…
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