Medications & Supplements/Prescription Drugs

SCA Pharmaceuticals, LLC: Sterile Admixtures Recalled Due to Potential for Leakage

Agency Publication Date: July 2, 2018

Summary

SCA Pharmaceuticals, LLC is voluntarily recalling approximately 11,025 units of various sterile admixtures, including Morphine Sulfate, Fentanyl, and Norepinephrine, because the bags and syringes may leak. These products were distributed to healthcare facilities throughout the United States between June and August 2018. If a container leaks, the sterility of the medication cannot be guaranteed, which could lead to serious infections for patients receiving these drugs intravenously.

Risk

A leak in the primary packaging of a sterile medication can allow bacteria or other contaminants to enter the product. If a patient is injected with a non-sterile medication, they face a significant risk of developing life-threatening infections such as sepsis.

What You Should Do

Identify if you have any of the affected products by checking the product name and lot numbers on the packaging. Affected items include Morphine Sulfate 1 mg/mL (Lot 20180323@44), Fentanyl (Lots 20180328@19, 20180328@31, 20180328@39, 20180328@49, 20180328@53, 20180328@58, 20180323@9, 20180327@33, 20180327@27, 20180327@40, 20180328@9), and Diltiazem HCL (Lots 1218001315, 1218001316, 1218001349, 1218001416, 1218001510, 1218001682, 1218001683, 1218001684, 1218001721, 1218001763, 1218001764).
Check for affected Norepinephrine Bitartrate lots (1218000928, 1218000944, 1218000945, 1218001075, 1218001076, 1218001188, 1218000930, 1218000946, 1218001058, 1218001077, 1218001169, 1218001170, 1218001190, 1218001191, 1218001206, 1218001317, 1218000677, 1218000947, 1218000982, 1218001018, 1218001029, 1218001059, 1218001060, 1218001078, 1218001079, 1218001171, 1218001172, 1218001192, 1218001193, 1218001207, 1218001209, 1218001210).
Check for affected Phenylephrine HCL lots (20180323@24, 20180323@29, 20180329@2, 20180328@25) with expiration dates ranging from June 21, 2018, to June 27, 2018.
If you are a patient who has received one of these medications and are experiencing unusual symptoms, contact your healthcare provider or pharmacist immediately.
Healthcare facilities should immediately stop using the affected lots, quarantine them, and return any unused products to the pharmacy or place of purchase for a refund.
Contact SCA Pharmaceuticals, LLC at their Windsor, Connecticut facility for further instructions regarding the return and replacement process.
For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare provider/pharmacist guidance and product return

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syringe

Model:

D-0894-2018

Lot Numbers:

20180323@44 (Exp 06/21/2018)

Date Ranges: Exp 06/21/2018

Product: Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag

Model:

D-0895-2018

Lot Numbers:

20180328@19

20180328@31

20180328@39

20180328@49

20180328@53

20180328@58

20180323@9

20180327@33

Date Ranges: Exp 6/26/2018

Product: Fentanyl (as citrate) 2 mcg/mL + Bupivacaine HCL 0.0625% in 0.9% Sodium Chloride 250 mL bag

Model:

D-0896-2018

Lot Numbers:

20180327@27

20180327@40

20180328@9

Date Ranges: Exp 06/28/2018

Product: Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag

Model:

D-0897-2018

Lot Numbers:

1218001315

1218001316

1218001349

1218001416

1218001510

1218001682

1218001683

1218001684

1218001721

1218001763

1218001764

Date Ranges: 07/26/2018-08/27/2018

Product: Norepinephrine Bitartrate 4 mg (16 mcg/mL) in 0.9% Sodium Chloride 250 mL bag

Model:

D-0898-2018

Lot Numbers:

1218000928

1218000944

1218000945

1218001075

1218001076

1218001188

Date Ranges: 06/19/2018-07/03/2018

Product: Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag

Model:

D-0899-2018

Lot Numbers:

1218000930

1218000946

1218001058

1218001077

1218001169

1218001170

1218001190

1218001191

1218001206

1218001317

Date Ranges: 06/18/2018-07/11/2018

Product: Norepinephrine Bitartrate 16 mg (64 mcg/mL) in 0.9% Sodium Chloride 250 mL bag

Model:

D-0900-2018

Lot Numbers:

1218000677

1218000947

1218000982

1218001018

1218001029

1218001059

1218001060

1218001078

1218001079

1218001171

1218001172

1218001192

1218001193

1218001207

1218001209

1218001210

Date Ranges: 06/19/2018-07/03/2018

Product: Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL)

Model:

D-0901-2018

Lot Numbers:

20180323@24 (Exp 06/21/2018)

Date Ranges: Exp 06/21/2018

Product: Phenylephrine HCL 40 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL)

Model:

D-0902-2018

Lot Numbers:

20180323@24

Product: Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL)

Model:

D-0903-2018

Lot Numbers:

20180323@29 (Exp 06/21/2018)

Date Ranges: Exp 06/21/2018

Product: Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag (200 mcg/mL)

Model:

D-0904-2018

Lot Numbers:

20180329@2 (Exp 06/27/2018)

Date Ranges: Exp 06/27/2018

Product: Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag (320 mcg/mL)

Model:

D-0905-2018

Lot Numbers:

20180328@25 (Exp 06/26/2018)

Date Ranges: Exp 06/26/2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80303

Status: Resolved

Manufacturer: SCA Pharmaceuticals, LLC

Sold By: Healthcare facilities; Hospitals

Manufactured In: United States

Units Affected: 11 products (440 syringes; 492 bags; 179 bags; 2,869 bags; 2,268 bags; 1,882 bags; 1,397 bags; 451 bags; 451 bags; 400 bags; 196 bags)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.

Summary

What You Should Do

Identify if you have any of the affected products by checking the product name and lot numbers on the packaging. Affected items include Morphine Sulfate 1 mg/mL (Lot 20180323@44), Fentanyl (Lots 20180328@19, 20180328@31, 20180328@39, 20180328@49, 20180328@53, 20180328@58, 20180323@9, 20180327@33, 20180327@27, 20180327@40, 20180328@9), and Diltiazem HCL (Lots 1218001315, 1218001316, 1218001349, 1218001416, 1218001510, 1218001682, 1218001683, 1218001684, 1218001721, 1218001763, 1218001764).

Check for affected Norepinephrine Bitartrate lots (1218000928, 1218000944, 1218000945, 1218001075, 1218001076, 1218001188, 1218000930, 1218000946, 1218001058, 1218001077, 1218001169, 1218001170, 1218001190, 1218001191, 1218001206, 1218001317, 1218000677, 1218000947, 1218000982, 1218001018, 1218001029, 1218001059, 1218001060, 1218001078, 1218001079, 1218001171, 1218001172, 1218001192, 1218001193, 1218001207, 1218001209, 1218001210).

Check for affected Phenylephrine HCL lots (20180323@24, 20180323@29, 20180329@2, 20180328@25) with expiration dates ranging from June 21, 2018, to June 27, 2018.

If you are a patient who has received one of these medications and are experiencing unusual symptoms, contact your healthcare provider or pharmacist immediately.

Healthcare facilities should immediately stop using the affected lots, quarantine them, and return any unused products to the pharmacy or place of purchase for a refund.

Contact SCA Pharmaceuticals, LLC at their Windsor, Connecticut facility for further instructions regarding the return and replacement process.

For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syringe

Model:

D-0894-2018

Lot Numbers:

20180323@44 (Exp 06/21/2018)

Date Ranges: Exp 06/21/2018

Product: Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag

Model:

D-0895-2018

Lot Numbers:

20180328@19

20180328@31

20180328@39

20180328@49

20180328@53

20180328@58

20180323@9

20180327@33

Date Ranges: Exp 6/26/2018

Product: Fentanyl (as citrate) 2 mcg/mL + Bupivacaine HCL 0.0625% in 0.9% Sodium Chloride 250 mL bag

Model:

D-0896-2018

Lot Numbers:

20180327@27

20180327@40

20180328@9

Date Ranges: Exp 06/28/2018

Product: Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag

Model:

D-0897-2018

Lot Numbers:

1218001315

1218001316

1218001349

1218001416

1218001510

1218001682

1218001683

1218001684

1218001721

1218001763

1218001764

Date Ranges: 07/26/2018-08/27/2018

Product: Norepinephrine Bitartrate 4 mg (16 mcg/mL) in 0.9% Sodium Chloride 250 mL bag

Model:

D-0898-2018

Lot Numbers:

1218000928

1218000944

1218000945

1218001075

1218001076

1218001188

Date Ranges: 06/19/2018-07/03/2018

Product: Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag

Model:

D-0899-2018

Lot Numbers:

1218000930

1218000946

1218001058

1218001077

1218001169

1218001170

1218001190

1218001191

1218001206

1218001317

Date Ranges: 06/18/2018-07/11/2018

Product: Norepinephrine Bitartrate 16 mg (64 mcg/mL) in 0.9% Sodium Chloride 250 mL bag

Model:

D-0900-2018

Lot Numbers:

1218000677

1218000947

1218000982

1218001018

1218001029

1218001059

1218001060

1218001078

1218001079

1218001171

1218001172

1218001192

1218001193

1218001207

1218001209

1218001210

Date Ranges: 06/19/2018-07/03/2018

Product: Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL)

Model:

D-0901-2018

Lot Numbers:

20180323@24 (Exp 06/21/2018)

Date Ranges: Exp 06/21/2018

Product: Phenylephrine HCL 40 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL)

Model:

D-0902-2018

Lot Numbers:

20180323@24

Product: Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL)

Model:

D-0903-2018

Lot Numbers:

20180323@29 (Exp 06/21/2018)

Date Ranges: Exp 06/21/2018

Product: Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag (200 mcg/mL)

Model:

D-0904-2018

Lot Numbers:

20180329@2 (Exp 06/27/2018)

Date Ranges: Exp 06/27/2018

Product: Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag (320 mcg/mL)

Model:

D-0905-2018

Lot Numbers:

20180328@25 (Exp 06/26/2018)

Date Ranges: Exp 06/26/2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80303

Status: Resolved

Manufacturer: SCA Pharmaceuticals, LLC

Sold By: Healthcare facilities; Hospitals

Manufactured In: United States

Units Affected: 11 products (440 syringes; 492 bags; 179 bags; 2,869 bags; 2,268 bags; 1,882 bags; 1,397 bags; 451 bags; 451 bags; 400 bags; 196 bags)

Distributed To: Nationwide