SCA Pharmaceuticals: Lack of Assurance of Sterility; product has the potential to leak.

Agency Publication Date: July 26, 2017

Affected Products

Product: BUPIVacaine HCl 0.1% PF (From 0.75%) in 0.9% Sodium Chloride, 250 mL Bag, Preservative Free (Waste From 250 mL Bag), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0060-40

Lots: 20170429@33 BUD: 7/28/2017, 20170503@23 BUD: 8/1/2017

Product: BUPIVacaine HCl 0.125% In 250 mL 0.9% Sodium Chloride Bag, Preservative Free (Total Dose Bupivacaine 312.5 mg per 250 mL), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0062-40

Lot: 20170502@32 BUD: 7/31/2017

Lot Numbers:

20170502

Product: BUPIVacaine HCl 0.2% IN 0.9% Sodium Chloride 250 mL Bag Preservative Free (Total Dose Bupivacaine 500 mg per 250 mL), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0066-40

Lot: 20170501@69 BUD: 7/30/2017

Lot Numbers:

20170501

Product: fentaNYL (as citrate) 5 mcg/mL In 250 mL 0.9% Sodium Chloride Injection Bag (Total fentaNYL Dose 1250 mcg/ 250 mL), Preservative Free, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0201-40

Lots: 20170428@57 BUD: 7/27/2017; 20170428@58 BUD: 7/27/2017; 20170511@24 BUD: 8/9/2017

Product: fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0202-40

Lots: 20170502@18 BUD: 7/31/2017; 20170502@39 BUD: 7/31/2017; 20170502@62 BUD: 7/31/2017; 20170503@22 BUD: 8/1/2017; 20170503@4 BUD: 8/1/2017; 20170503@54 BUD: 8/1/2017; 20170504@10 BUD: 8/2/2017; 20170505@15 BUD: 8/3/2017; 20170506@23 BUD: 8/4/2017

Product: fentaNYL as citrate 5 mcg/mL in 0.9% Sodium Chloride 1 mL in Single Dose syringe, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0225-24

Lot: 20170510@40 BUD: 8/8/2017

Lot Numbers:

20170510

Product: fentaNYL 2 mcg/mL+Bupivacaine 0.0625% PF in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0226-40

Lots: 20170429@29 BUD: 7/28/2017; 20170512@24 BUD: 8/10/2017

Product: fentaNYL 10 mcg/mL PF in NS 1 mL Fill in 3 mL syringe, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0229-05

Lot: 20170512@19 BUD: 8/10/2017

Lot Numbers:

20170512

Product: fentaNYL 10 mcg/mL PF in Sodium Chloride 250 mL (Total Dose=2500 mcg), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0229-40

Lots: 20170509@20 BUD: 8/7/2017; 20170509@21 BUD: 8/7/2017; 20170509@46 BUD: 8/7/2017; 20170511@33 BUD: 8/9/2017

Product: fentaNYL 2 mcg/mL + BUPIvacaine 0.1% PF in 0.9% NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0230-40

Lots: 20170502@47 BUD: 7/31/2017; 20170502@56 BUD: 7/31/2017; 20170505@26 BUD: 8/3/2017; 20170506@25 BUD: 8/4/2017

Product: fentaNYL 2 mcg/mL + BUPIvacaine 0.125% PF in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0254-40

Lots: 20170503@75 BUD: 8/1/2017; 20170511@21 BUD: 8/9/2017

Product: fentaNYL 3 mcg/mL + BUPIvacaine 0.1% in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0290-40

Lot: 20170506@27 BUD: 8/4/2017

Lot Numbers:

20170506

Product: Hydromorphone 0.5 mg/mL in 0.9% Sodium Chloride 1 mL Fill in 3 mL BD syringe, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0302-05

Lot: 20170508@75 BUD: 8/6/2017

Lot Numbers:

20170508

Product: ePHEDrine Sulfate 5 mg/mL in NS 5 mL Fill in 12 mL Syringe (25 mg), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0600-11

Lots: 20170503@28 BUD: 7/17/2017; 20170508@60 BUD: 7/22/2017

Product: EPINEPHrine HCl 4 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0613-40

Lots: 20170508@51 BUD: 9/10/2017; 20170503@17 BUD: 9/5/2017

Product: NORepinephrine 4 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0771-40

Lots: 20170502@36 BUD: 7/31/2017; 20170512@1 BUD: 8/10/2017; 20170504@13 BUD: 8/2/2017; 20170504@18 BUD: 8/2/2017

Product: NORepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0774-40

Lots: 20170502@31 BUD: 7/16/2017; 20170508@34 BUD: 7/22/2017; 20170508@70 BUD: 7/22/2017; 20170512@15 BUD: 7/26/2017

Product: NORepinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0775-40

Lots: 20170512@8 BUD: 8/10/2017; 20170506@18 BUD: 8/4/2017

Product: PHENYLephrine HCl 60 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0809-40

Lots: 20170502@53 BUD: 7/31/2017; 20170505@16 BUD: 8/3/2017

Product: PHENYLephrine HCl 25 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0810-40

Lots: 20170512@20 BUD: 8/10/2017; 20170504@61 BUD: 8/2/2017

Product: PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride 250 mL Bag, Preservative Free, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0811-40

Lots: 20170503@26 BUD: 8/1/2017; 20170510@48 BUD: 8/8/2017

Product: PHENYLephrine 10 mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0811-59

Lots: 20170503@29 BUD: 8/1/2017; 20170512@22 BUD: 8/10/2017; 20170509@64 BUD: 8/7/2017

Product: PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0812-40

Lots: 20170429@28 BUD: 7/28/2017; BUD: 20170509@65 BUD: 8/7/2017

Product: PHENYLephrine 100 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 882PHENYLephrine 100 mg 1 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0813-40

Lot: 20170503@16 BUD: 8/1/2017

Lot Numbers:

20170503

Product: PHENYLephrine 200 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0815-40

Lot: 20170511@51 BUD: 8/9/2017

Lot Numbers:

20170511

Product: PHENYLephrine 20 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0816-40

Lot: 20170503@19 BUD: 8/1/2017

Lot Numbers:

20170503

Product: PHENYLephrine 50 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0820-40

Lots: 20170512@6 BUD: 8/10/2017; 20170511@56 BUD: 8/9/2017

Product: Potassium Chloride 20 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0832-40

Lots: 20170501@66 BUD: 7/15/2017

Product: Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0833-40

Lots: 20170509@10 BUD: 7/23/2017

Product: fentaNYL 2 mcg/mL + Ropivacaine 0.2% PF in NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0260-40

Lots: 20170509@17 BUD: 8/7/2017

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 77770

Status: Resolved

Manufacturer: SCA Pharmaceuticals

Manufactured In: United States

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Lots: 20170429@33 BUD: 7/28/2017, 20170503@23 BUD: 8/1/2017

Lot: 20170502@32 BUD: 7/31/2017

Lot Numbers:

20170502

Lot: 20170501@69 BUD: 7/30/2017

Lot Numbers:

20170501

Lots: 20170428@57 BUD: 7/27/2017; 20170428@58 BUD: 7/27/2017; 20170511@24 BUD: 8/9/2017

Product: fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0202-40

Product: fentaNYL as citrate 5 mcg/mL in 0.9% Sodium Chloride 1 mL in Single Dose syringe, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0225-24

Lot: 20170510@40 BUD: 8/8/2017

Lot Numbers:

20170510

Product: fentaNYL 2 mcg/mL+Bupivacaine 0.0625% PF in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0226-40

Lots: 20170429@29 BUD: 7/28/2017; 20170512@24 BUD: 8/10/2017

Product: fentaNYL 10 mcg/mL PF in NS 1 mL Fill in 3 mL syringe, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0229-05

Lot: 20170512@19 BUD: 8/10/2017

Lot Numbers:

20170512

Product: fentaNYL 10 mcg/mL PF in Sodium Chloride 250 mL (Total Dose=2500 mcg), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0229-40

Lots: 20170509@20 BUD: 8/7/2017; 20170509@21 BUD: 8/7/2017; 20170509@46 BUD: 8/7/2017; 20170511@33 BUD: 8/9/2017

Product: fentaNYL 2 mcg/mL + BUPIvacaine 0.1% PF in 0.9% NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0230-40

Lots: 20170502@47 BUD: 7/31/2017; 20170502@56 BUD: 7/31/2017; 20170505@26 BUD: 8/3/2017; 20170506@25 BUD: 8/4/2017

Product: fentaNYL 2 mcg/mL + BUPIvacaine 0.125% PF in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0254-40

Lots: 20170503@75 BUD: 8/1/2017; 20170511@21 BUD: 8/9/2017

Product: fentaNYL 3 mcg/mL + BUPIvacaine 0.1% in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0290-40

Lot: 20170506@27 BUD: 8/4/2017

Lot Numbers:

20170506

Product: Hydromorphone 0.5 mg/mL in 0.9% Sodium Chloride 1 mL Fill in 3 mL BD syringe, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0302-05

Lot: 20170508@75 BUD: 8/6/2017

Lot Numbers:

20170508

Product: ePHEDrine Sulfate 5 mg/mL in NS 5 mL Fill in 12 mL Syringe (25 mg), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0600-11

Lots: 20170503@28 BUD: 7/17/2017; 20170508@60 BUD: 7/22/2017

Product: EPINEPHrine HCl 4 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0613-40

Lots: 20170508@51 BUD: 9/10/2017; 20170503@17 BUD: 9/5/2017

Product: NORepinephrine 4 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0771-40

Lots: 20170502@36 BUD: 7/31/2017; 20170512@1 BUD: 8/10/2017; 20170504@13 BUD: 8/2/2017; 20170504@18 BUD: 8/2/2017

Product: NORepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0774-40

Lots: 20170502@31 BUD: 7/16/2017; 20170508@34 BUD: 7/22/2017; 20170508@70 BUD: 7/22/2017; 20170512@15 BUD: 7/26/2017

Product: NORepinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0775-40

Lots: 20170512@8 BUD: 8/10/2017; 20170506@18 BUD: 8/4/2017

Product: PHENYLephrine HCl 60 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0809-40

Lots: 20170502@53 BUD: 7/31/2017; 20170505@16 BUD: 8/3/2017

Product: PHENYLephrine HCl 25 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0810-40

Lots: 20170512@20 BUD: 8/10/2017; 20170504@61 BUD: 8/2/2017

Product: PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride 250 mL Bag, Preservative Free, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0811-40

Lots: 20170503@26 BUD: 8/1/2017; 20170510@48 BUD: 8/8/2017

Product: PHENYLephrine 10 mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0811-59

Lots: 20170503@29 BUD: 8/1/2017; 20170512@22 BUD: 8/10/2017; 20170509@64 BUD: 8/7/2017

Product: PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0812-40

Lots: 20170429@28 BUD: 7/28/2017; BUD: 20170509@65 BUD: 8/7/2017

Product: PHENYLephrine 100 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 882PHENYLephrine 100 mg 1 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0813-40

Lot: 20170503@16 BUD: 8/1/2017

Lot Numbers:

20170503

Product: PHENYLephrine 200 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0815-40

Lot: 20170511@51 BUD: 8/9/2017

Lot Numbers:

20170511

Product: PHENYLephrine 20 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0816-40

Lot: 20170503@19 BUD: 8/1/2017

Lot Numbers:

20170503

Product: PHENYLephrine 50 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0820-40

Lots: 20170512@6 BUD: 8/10/2017; 20170511@56 BUD: 8/9/2017

Product: Potassium Chloride 20 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0832-40

Lots: 20170501@66 BUD: 7/15/2017

Product: Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0833-40

Lots: 20170509@10 BUD: 7/23/2017

Product: fentaNYL 2 mcg/mL + Ropivacaine 0.2% PF in NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0260-40

Lots: 20170509@17 BUD: 8/7/2017