FDA (Drugs) recall action 78320

SCA Pharmaceuticals, LLC recalled 10 products on 2017-11-08

The FDA (Drugs) publishes a recall like this one as 10 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 10 pages.

Products: 10
Announced: 2017-11-08
Critical: 0
Units: 3,806

Why these products were recalled

Lack Of Assurance Of Sterility.

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.

1–10 of 10

SevereFDA (Drugs)··2017-11-08
SCA Pharmaceuticals Recalls Morphine Sulfate Due to Sterility Concerns
SCA Pharmaceuticals is recalling specific lots of morphine sulfate injection due to a lack of assurance of sterility.
Product
morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total Volume 100 mL in Single Dose CADD Cassette (Total morphine Dose 100 mg per 100 mL) (NDC 70004-0100-63) b) Total Volume 50 mL in Single Dose Syringe (Total morphine Dose 50 mg / 50 mL) (NDC 70004-0100-22) Rx Only, SCA
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0 states
SevereFDA (Drugs)··2017-11-08
SCA Pharmaceuticals Recalls Rocuronium Bromide Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 487 syringes of Rocuronium Bromide 10 mg/mL due to a lack of assurance of sterility. The product was distributed nationwide.
Product
ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5 mL Total Dose) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-850-09
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0 states
SevereFDA (Drugs)··2017-11-08
SCA Pharmaceuticals Recalls Fentanyl and Ropivacaine CADD Cassettes
SCA Pharmaceuticals is recalling specific lots of fentanyl and ropivacaine CADD cassettes due to a lack of assurance of sterility.
Product
fentaNYL as citrate 2 mcg / mL, ROPIVacaine HCl 0.1%, Total Fentanyl Dose (200 mcg per 100 mL) in 0.9% Sodium Chloride single dose CADD Cassette Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0264-64
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0 states
SevereFDA (Drugs)··2017-11-08
SCA Pharmaceuticals Recalls Succinylcholine Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 1,248 syringes of Succinylcholine 20 mg/mL due to a lack of assurance of sterility. The product was distributed nationwide.
Product
SUCcinylcholine 20 mg per mL, Total Volume 10 mL in single-dose syringe, (SUCcinylcholine 200 mg / 10 ml) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0910-29
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0 states
SevereFDA (Drugs)··2017-11-08
SCA Pharmaceuticals Recalls Hydromorphone and Bupivacaine Injection Bags
SCA Pharmaceuticals is recalling 60 bags of Hydromorphone and Bupivacaine injection due to a lack of assurance of sterility.
Product
HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9% Sodium Chloride 50 mL (HYDROmorphone Total Dose 1000 mcg) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0331-22
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0 states
SevereFDA (Drugs)··2017-11-08
SCA Pharmaceuticals Recalls Hydromorphone Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 128 syringes of Hydromorphone HCL 1 mg/mL due to a lack of assurance of sterility. The product was distributed nationwide.
Product
HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill in 30 mL single-dose syringe (Total Dose Hydromorphone 25 mg/25 mL) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0303-17
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0 states
SevereFDA (Drugs)··2017-11-08
SCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Injection Bags
SCA Pharmaceuticals is recalling 116 bags of fentanyl and bupivacaine injection due to a lack of assurance of sterility.
Product
fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250 mL) in 0.9% Sodium Chloride 250 mL Bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205. NDC 70004-0231-40
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0 states
SevereFDA (Drugs)··2017-11-08
SCA Pharmaceuticals Recalls Oxytocin Bags Due to Sterility Concerns
SCA Pharmaceuticals is recalling 450 bags of oxyTOCIN 30 units in Lactated Ringers due to a lack of assurance of sterility.
Product
oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag, Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0086-44
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0 states
SevereFDA (Drugs)··2017-11-08
SCA Pharmaceuticals Recalls Calcium Gluconate Bags Due to Sterility Concerns
SCA Pharmaceuticals is recalling 76 bags of Calcium Gluconate 2 g in 0.9% Sodium Chloride due to a lack of assurance of sterility.
Product
Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride 50 mL Bag, Each bag contains 9.3 mEq Ca++ Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0510-30
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0 states
SevereFDA (Drugs)··2017-11-08
SCA Pharmaceuticals Recalls Phenylephrine Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 1,221 syringes of Phenylephrine HCl 100 mcg/mL due to a lack of assurance of sterility.
Product
PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL Fill Volume in a Single Dose Syringe (1,000 mcg / 10 ml Total Dose), Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR, NDC 70004-0810-12
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0 states