The Recall Desk

FDA (Drugs) recall action 86990

SCA Pharmaceuticals recalled 32 products on 2021-01-13

The FDA (Drugs) publishes a recall like this one as 32 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 32 pages.

Products
32
Announced
2021-01-13
Critical
0
Units
168,250

Why these products were recalled

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

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 32

  • SevereFDA (Drugs)··2021-01-13

    SCA Pharmaceuticals Recalls Hydromorphone Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 1,056 hydromorphone syringes because a defective cap may compromise sterility. The product was distributed to hospitals nationwide.

    Product
    HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) 30 mL Plungerless Single Dose Syringe (barcode 70004030316) and b) 30 mL Single Dose Syringe (barcode 70004030321), Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095
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    0 states
  • SevereFDA (Drugs)··2021-01-13

    SCA Pharmaceuticals Recalls Morphine Sulfate Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling specific lots of morphine sulfate injection syringes due to a lack of assurance of sterility and potential defective caps.

    Product
    morphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection, (5 mg/mL), Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010316
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    0 states
  • SevereFDA (Drugs)··2021-01-13

    SCA Pharmaceuticals Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 5,067 syringes of Succinylcholine Chloride 100 mg/5mL due to a lack of assurance of sterility and potential defective caps.

    Product
    SUCcinylcholine Chloride 100 mg/5mL, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., WIndsor, CT, 06095, barcode 70004090809
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    Distribution
    0 states
  • SevereFDA (Drugs)··2021-01-13

    SCA Pharmaceuticals Recalls Lidocaine HCl Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling Lidocaine HCl 1% syringes due to a lack of assurance of sterility and potential defective caps.

    Product
    Lidocaine HCl 1% 10 mL (10mg/ml), Rx Only, 1 mL Single Dose Syringe, SCA Pharma, Inc., 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072012
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    0 states
  • SevereFDA (Drugs)··2021-01-13

    SCA Pharmaceuticals Recalls Lidocaine HCl Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 7,275 syringes of Lidocaine HCl 2% because defective caps may compromise sterility. The product was distributed to hospitals nationwide.

    Product
    Lidocaine HCl 2% 5 mL, 20 mg/mL, Rx Only, 5 mL syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072309
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    0 states
  • SevereFDA (Drugs)··2021-01-13

    SCA Pharmaceuticals Recalls Fentanyl Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling fentanyl syringes because a defective cap may compromise sterility. The product was distributed to hospitals nationwide.

    Product
    fentaNYL 1500 mcg/30 mL (50 mcg/mL), 30 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004020016
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2021-01-13

    SCA Pharmaceuticals Recalls Hydromorphone Injection Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 428 syringes of Hydromorphone HCl injection due to a lack of assurance of sterility and potential defective syringe caps.

    Product
    HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection, CII, Rx Only, 50 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004030022
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    0 states
  • SevereFDA (Drugs)··2021-01-13

    SCA Pharmaceuticals Recalls Buffered Lidocaine Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 3,793 syringes of Buffered Lidocaine HCl due to a potential defective cap that compromises sterility. The product was distributed to hospitals nationwide.

    Product
    Buffered Lidocaine HCl, 1%, 5 mL (10mg/mL) with Sodium Bicarbonate Injection for Local Anesthetic Use, 5 mL Single Dose Syringe, Rx Only SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072509
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    0 states
  • SevereFDA (Drugs)··2021-01-13

    SCA Pharmaceuticals Recalls Phenylephrine Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 14,580 syringes of Phenylephrine HCl due to a lack of assurance of sterility and potential defective caps.

    Product
    PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride (100 mcg/mL), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081011
    Category
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    0 states
  • SevereFDA (Drugs)··2021-01-13

    SCA Pharmaceuticals Recalls Rocuronium Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 7,940 syringes of Rocuronium Br 100 mg/10mL because defective caps may compromise sterility. The product was distributed to hospitals nationwide.

    Product
    Rocuronium Br 100 mg/10mL (10 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR, 72205, barcode 70004085012
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    0 states
  • SevereFDA (Drugs)··2021-01-13

    SCA Pharmaceuticals Recalls Neostigmine Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 390 syringes of neostigmine methylsulfate due to a lack of assurance of sterility and potential defective caps.

    Product
    neostigmine methylsulfate 5 mg/5 mL, (1mg/ml), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004075009
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    0 states
  • SevereFDA (Drugs)··2021-01-13

    SCA Pharmaceuticals Recalls ePHEDrine Injection Due to Sterility Concerns

    SCA Pharmaceuticals is recalling ePHEDrine 25 mg/5 mL Injection syringes because a defective cap may compromise sterility. The product was distributed to hospitals nationwide.

    Product
    ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals 8521 Knoedl Ct., Little Rock, AR, 72205, barcode 70004060409
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    0 states
  • SevereFDA (Drugs)··2021-01-13

    SCA Pharmaceuticals Recalls Fentanyl and Ropivacaine Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling specific lots of fentanyl and ropivacaine syringes due to a lack of assurance of sterility and potential defective caps.

    Product
    fentaNYL 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004026422
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    0 states
  • SevereFDA (Drugs)··2021-01-13

    SCA Pharmaceuticals Recalls Atropine Sulfate Injection Due to Sterility Concerns

    SCA Pharmaceuticals is recalling Atropine Sulfate Injection syringes due to a lack of assurance of sterility and potential defective caps.

    Product
    Atropine Sulfate Injection, 0.8 mg/2 mL (0.4 mg/mL), 2 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004004006
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    0 states
  • SevereFDA (Drugs)··2021-01-13

    SCA Pharmaceuticals Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 3,239 syringes of Succinylcholine Chloride 200 mg/10 mL due to a lack of assurance of sterility and potential defective caps.

    Product
    SUCccinylcholine Chloride 200 mg/10 mL, (20 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090812
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2021-01-13

    SCA Pharmaceuticals Recalls Phenylephrine Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 3,152 single-dose syringes of Phenylephrine HCl due to a lack of assurance of sterility and potential defective caps.

    Product
    PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081022
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2021-01-13

    SCA Pharmaceuticals Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 1,879 syringes of ePHEDrine Sulfate injection due to a lack of assurance of sterility and potential defective syringe caps.

    Product
    ePHEDrine Sulfate, 50 mg/5mL in 0.9% Sodium Chloride Injection, 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004060509
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    0 states
  • SevereFDA (Drugs)··2021-01-13

    SCA Pharmaceuticals Recalls ePHEDrine Sulfate Injection Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 7,257 syringes of ePHEDrine Sulfate Injection due to a lack of assurance of sterility and potential defective syringe caps.

    Product
    ePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection, 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004060412
    Category
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    0 states
  • SevereFDA (Drugs)··2021-01-13

    SCA Pharmaceuticals Recalls Ketamine Injection Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 9,942 syringes of Ketamine 50 mg/5mL injection due to a lack of assurance of sterility and potential defective syringe caps.

    Product
    Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043009
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    0 states
  • SevereFDA (Drugs)··2021-01-13

    SCA Pharmaceuticals Recalls Glycopyrrolate Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 1,614 syringes of Glycopyrrolate 1 mg/5mL due to a lack of assurance of sterility and potential defective caps.

    Product
    Glycopyrrolate 1 mg/5mL (0.2mg/mL), 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004063809
    Category
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    0 states
  • SevereFDA (Drugs)··2021-01-13

    SCA Pharmaceuticals Recalls Fentanyl Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 6,710 fentanyl syringes distributed to hospitals nationwide due to a lack of assurance of sterility and potential defective caps.

    Product
    fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004020006
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2021-01-13

    SCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 996 fentanyl and bupivacaine syringes due to a lack of assurance of sterility and potential defective caps.

    Product
    fentaNYL 100 mcg/50mL Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals,755 Rainbow Rd., Windsor, CT, 06095, barcode 70004023122
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    0 states
  • ModerateFDA (Drugs)··2021-01-13

    SCA Pharmaceuticals Recalls Morphine Sulfate Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 751 syringes of Morphine Sulfate 3 mg/3 mL due to a lack of assurance of sterility and potential defective caps.

    Product
    Morphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride (1mg/mL) CII, Rx Only, 3 ml Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010025
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    0 states
  • SevereFDA (Drugs)··2021-01-13

    SCA Pharmaceuticals Recalls Sodium Citrate Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 5,990 syringes of Sodium Citrate 4% Anticoagulation Solution due to a lack of assurance of sterility and potential defective caps.

    Product
    Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL), Rx only, 3 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090025
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    0 states
  • SevereFDA (Drugs)··2021-01-13

    SCA Pharmaceuticals Recalls Esmolol Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 952 syringes of Esmolol HCl 100 mg/10 mL due to a lack of assurance of sterility and potential defective caps.

    Product
    Esmolol HCl 100 mg/10 mL (10mg/ mL), 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004062012
    Category
    Distribution
    0 states