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.

26–50 of 75

SevereFDA (Drugs)··2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate
PharMEDium Services is recalling 700 bags of compounded fentanyl and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.
Product
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
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HighFDA (Drugs)··2016-07-27
PharMEDium Recalls Bupivacaine HCl Injectable Bags Due to Glass Particulate
PharMEDium Services is recalling 4,081 bags of 0.1% Bupivacaine HCl injectable solution because the active ingredient was contaminated with glass particulate matter.
Product
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…
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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…
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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 Sterile Injectable Drugs Contaminated With Glass Particulate Matter
Pharmedium Services, LLC is recalling 25 bags of compounded sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of glass particulate matter.
Product
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
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SevereFDA (Drugs)··2016-07-27
PharMEDium Recalls Sterile Injectable Drugs Contaminated With Glass Particulate
PharMEDium Services is recalling 90 bags of sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of glass particulate matter.
Product
5 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8233, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-233-54
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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…
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SevereFDA (Drugs)··2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulates
Pharmedium Services, LLC is recalling 180 syringes of compounded Fentanyl Citrate and Bupivacaine HCl because the active ingredient was contaminated with glass particulate matter.
Product
6.66 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 15 mL in 20 mL BD Syringe, Service Code 2T6993Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-993-86
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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…
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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…
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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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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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SevereFDA (Drugs)··2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Injectable Due to Glass Particulate
Pharmedium Services, LLC is recalling specific lots of compounded Fentanyl Citrate and Bupivacaine HCl injectable solutions because they were produced using an API contaminated with glass particulate matter.
Product
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
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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 Cassettes Due to Glass Particulate
PharMEDium Services, LLC is recalling 384 cassettes of Fentanyl Citrate and Bupivacaine HCl because the active ingredient was contaminated with glass particulate matter.
Product
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…
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SevereFDA (Drugs)··2016-07-27
PharMEDium Recalls Bupivacaine HCl Due to Glass Particulate Contamination
PharMEDium Services, LLC is recalling 2,194 bags and cassettes of 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride because the active pharmaceutical ingredient was contaminated with glass particulate matter.
Product
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…
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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 Fentanyl and Bupivacaine Bags Due to Glass Particulate
Pharmedium Services is recalling 1,527 bags of compounded fentanyl and bupivacaine injectable solution because glass particulate was found in the active pharmaceutical ingredient.
Product
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
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SevereFDA (Drugs)··2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulate
Pharmedium Services is recalling specific lots of compounded fentanyl and bupivacaine syringes because the active ingredient was contaminated with glass particulate matter.
Product
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…
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SevereFDA (Drugs)··2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Injectable Bags Due to Glass Particulates
PharMEDium Services is recalling 425 bags of compounded fentanyl and bupivacaine injectable solutions nationwide due to the presence of glass particulate matter.
Product
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
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SevereFDA (Drugs)··2016-07-27
Pharmedium Recalls Bupivacaine HCl Due to Glass Particulate Contamination
Pharmedium Services, LLC is recalling 177 cassettes of 0.03% Bupivacaine HCl because the active ingredient was contaminated with glass particulate matter.
Product
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
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SevereFDA (Drugs)··2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulates
Pharmedium Services is recalling 3,828 syringes of compounded fentanyl and bupivacaine because the active ingredient was contaminated with glass particulate matter.
Product
4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL Monoject Syringe, Service Code 2K8983, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-983-48
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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 Fentanyl and Bupivacaine Bags Due to Glass Particulates
Pharmedium Services, LLC is recalling 750 bags of compounded Fentanyl Citrate and Bupivacaine HCl injectable solution distributed nationwide due to the presence of glass particulate matter.
Product
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
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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…
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