Medications & Supplements/Prescription Drugs

Guardian Pharmacy Services: Various Compounded Injectable Drugs Recalled for Lack of Sterility

Agency Publication Date: August 8, 2018

Summary

Guardian Pharmacy Services is recalling 19,768 units of various compounded injectable medications, including Morphine Sulfate, Ascorbic Acid, and Fentanyl Citrate, due to a lack of sterility assurance. These products are intended to be sterile, and a failure in sterility can lead to serious infections. The affected medications were distributed in Texas and include various forms like syringes, vials, and IV bags produced in early 2018.

Risk

Administering a drug intended for injection that is not sterile can introduce bacteria or other contaminants directly into the bloodstream or body tissue, potentially causing life-threatening infections. No injuries or illnesses have been reported to date, but the medium risk level reflects the potential for severe health consequences from non-sterile compounded drugs.

What You Should Do

Check your medication packaging for 'Compounded Guardian Pharmacy Services' and identify if your product matches the specific lot numbers and 'Use By' dates listed in the affected products section.
Specific lots to look for include Morphine Sulfate (Lots 58440:42, 58624:42, 58962:42), Ascorbic Acid (Lots 58495:42, 58703/58733, 58852:42, 59006:42, 58555:42, 58567:42, 58563:42, 58547:42, 58565:42), and Fentanyl Citrate (Lot 58854:42) among others.
Immediately stop using any affected medication and contact your doctor or healthcare provider if you have experienced any problems that may be related to using these drug products.
Return any unused product to the pharmacy or place of purchase for a refund and contact Guardian Pharmacy Services for further instructions on disposal.
For additional questions or to report a problem, 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

Contact healthcare provider or pharmacy for refund/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 CADD (25 mL)

Model:

D-1051-2018

Lot Numbers:

58440:42

58624:42

58962:42

Date Ranges: Use By 05/23/2018, Use By 06/11/2018, Use By 07/11/2018

Product: Ascorbic Acid 500 mg/mL (100 mL vial)

Model:

D-1052-2018

Lot Numbers:

58495:42

58703/58733

58852:42

59006:42

Date Ranges: Use By 05/22/2018, Use By 06/10/2018, Use By 06/22/2018, Use By 07/10/2018

Product: Ascorbic Acid 500 mg/mL TPN (500 mL bag)

Model:

D-1053-2018

Lot Numbers:

58555:42

58567:42

58563:42

58547:42

58565:42

Date Ranges: Use By 05/25/2018

Product: B-Complex (100 mL bag/vial)

Model:

D-1054-2018

Lot Numbers:

58572:42

58768:42

Date Ranges: Use By 05/29/2018, Use By 06/20/2018

Product: EDTA Disodium 30 mg/mL PF (1 mL syringe)

Model:

D-1055-2018

Lot Numbers:

58897:42

Date Ranges: Use By 07/04/2018

Product: Glutathione 200 mg/mL (100 mL vial)

Model:

D-1056-2018

Lot Numbers:

58436:42

58653:42

58773:42

58766:42

Date Ranges: Use By 05/22/2018, Use By 06/12/2018, Use By 06/21/2018, Use By 06/20/2018

Product: Glycopyrrolate 0.2 mg/mL (2 mL syringe)

Model:

D-1057-2018

Lot Numbers:

58811:93

Date Ranges: Use By 06/18/2018

Product: Hyaluronidase 150 units/mL (1 mL vial)

Model:

D-1058-2018

Lot Numbers:

58895:42

Date Ranges: Use By 06/27/2018

Product: Hyaluronidase 150 units/mL (1 mL syringe)

Model:

D-1059-2018

Lot Numbers:

58895:42

58856:42

Date Ranges: Use By 06/27/2018, Use By 06/21/2018

Product: Magnesium Sulfate 200 mg/mL (100 mL vial)

Model:

D-1060-2018

Lot Numbers:

58212:42

Date Ranges: Use By 06/01/2018

Product: Medroxyprogesterone 150 mg/mL (5 mL vial)

Model:

D-1061-2018

Lot Numbers:

58611:42

59099:42

58786:42

Date Ranges: Use By 06/07/2018, Use By 07/24/2018, Use By 06/24/2018

Product: Methylene Blue 10 mg/mL (1 mL syringe)

Model:

D-1062-2018

Lot Numbers:

59185:42

58471:42

58745:42

Date Ranges: Use By 07/30/2018, Use By 05/27/2018, Use By 06/10/2018

Product: Fentanyl Citrate 50 mcg/mL (2 mL syringe)

Model:

D-1063-2018

Lot Numbers:

58854:42

Date Ranges: Use By 06/28/2018

Product: Ropivacaine HCl 2 mg/mL (400 mL ON-Q Pump)

Model:

D-1064-2018

Lot Numbers:

59088:42

59159:42

Date Ranges: Use By 05/24/2018, Use By 05/30/2018

Product: Ropivacaine HCl 2 mg/mL (550 mL ON-Q Pump)

Model:

D-1065-2018

Lot Numbers:

59086:42

59163:42

Date Ranges: Use By 05/24/2018, Use By 05/30/2018

Product: Ropivacaine HCl 2 mg/mL (750 mL ON-Q Pump)

Model:

D-1066-2018

Lot Numbers:

59103:42

Date Ranges: Use By 05/25/2018

Product: Cefazolin 2 Gm/20 mL (20 mL syringe)

Model:

D-1067-2018

Lot Numbers:

58758

58760

58756

59095:42

59093:42

59091:42

Product: Glutathione 200 mg/mL (50 mL vial)

Model:

D-1068-2018

Lot Numbers:

58653:42

58773/58766

58766:42

Date Ranges: Use By 06/12/2018, Use By 06/21/2018, Use By 06/20/2018

Product: Lidocaine 3% (10 mL syringe)

Model:

D-1069-2018

Lot Numbers:

58641:42

58775:42

59077:42

Date Ranges: Use By 06/04/2018, Use By 06/16/2018, Use By 07/17/2018

Product: Glutathione 200 mg/mL 50 mL MDV

Model:

D-1070-2018

Lot Numbers:

59097:42

Date Ranges: Use By 07/23/2018

Product: Methylcobalamin 1000 mcg/mL (100 mL vial)

Model:

D-1071-2018

Lot Numbers:

58409:42

58899:42

59215:42

Date Ranges: Use By 05/21/2018, Use By 07/04/2018, Use By 08/01/2018

Product: MIC 'B' COMBO LIPOTROPIC (50 mL vial)

Model:

D-1072-2018

Lot Numbers:

58618:42

Date Ranges: Use By 06/10/2018

Product: Phenol 6% with Glycerin Inj (10 mL vial)

Model:

D-1073-2018

Lot Numbers:

58913:42

Date Ranges: Use By 06/05/2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80118

Status: Resolved

Manufacturer: Guardian Pharmacy Services

Sold By: Guardian Pharmacy Services

Manufactured In: United States

Units Affected: 23 products (20 25-ml CADD; 4900 100-ml vials; 5000 500-ml bags; 2600 100 ml bags/vials; 1 1-ml syringe; 2400 100-ml vials; 100 2-ml syringes; 2 1-ml vials; 442 1-ml syringes; 1000 100-ml vials; 60 5-ml vials; 95 1-ml syringes; 300 2-ml syringes; 20 400-ml ON-Q Pump; 25 550-ml ON-Q Pump; 3 750-ml ON-Q Pump; 60 20-ml syringes; 100 50-ml vials; 250 10-ml syringes; 100 50-ml vials; 2000 100-ml vials; 250 50-ml vials; 40 10-ml vials)

Distributed To: Texas

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

Risk

What You Should Do

Check your medication packaging for 'Compounded Guardian Pharmacy Services' and identify if your product matches the specific lot numbers and 'Use By' dates listed in the affected products section.

Specific lots to look for include Morphine Sulfate (Lots 58440:42, 58624:42, 58962:42), Ascorbic Acid (Lots 58495:42, 58703/58733, 58852:42, 59006:42, 58555:42, 58567:42, 58563:42, 58547:42, 58565:42), and Fentanyl Citrate (Lot 58854:42) among others.

Immediately stop using any affected medication and contact your doctor or healthcare provider if you have experienced any problems that may be related to using these drug products.

Return any unused product to the pharmacy or place of purchase for a refund and contact Guardian Pharmacy Services for further instructions on disposal.

For additional questions or to report a problem, 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 CADD (25 mL)

Model:

D-1051-2018

Lot Numbers:

58440:42

58624:42

58962:42

Date Ranges: Use By 05/23/2018, Use By 06/11/2018, Use By 07/11/2018

Product: Ascorbic Acid 500 mg/mL (100 mL vial)

Model:

D-1052-2018

Lot Numbers:

58495:42

58703/58733

58852:42

59006:42

Date Ranges: Use By 05/22/2018, Use By 06/10/2018, Use By 06/22/2018, Use By 07/10/2018

Product: Ascorbic Acid 500 mg/mL TPN (500 mL bag)

Model:

D-1053-2018

Lot Numbers:

58555:42

58567:42

58563:42

58547:42

58565:42

Date Ranges: Use By 05/25/2018

Product: B-Complex (100 mL bag/vial)

Model:

D-1054-2018

Lot Numbers:

58572:42

58768:42

Date Ranges: Use By 05/29/2018, Use By 06/20/2018

Product: EDTA Disodium 30 mg/mL PF (1 mL syringe)

Model:

D-1055-2018

Lot Numbers:

58897:42

Date Ranges: Use By 07/04/2018

Product: Glutathione 200 mg/mL (100 mL vial)

Model:

D-1056-2018

Lot Numbers:

58436:42

58653:42

58773:42

58766:42

Date Ranges: Use By 05/22/2018, Use By 06/12/2018, Use By 06/21/2018, Use By 06/20/2018

Product: Glycopyrrolate 0.2 mg/mL (2 mL syringe)

Model:

D-1057-2018

Lot Numbers:

58811:93

Date Ranges: Use By 06/18/2018

Product: Hyaluronidase 150 units/mL (1 mL vial)

Model:

D-1058-2018

Lot Numbers:

58895:42

Date Ranges: Use By 06/27/2018

Product: Hyaluronidase 150 units/mL (1 mL syringe)

Model:

D-1059-2018

Lot Numbers:

58895:42

58856:42

Date Ranges: Use By 06/27/2018, Use By 06/21/2018

Product: Magnesium Sulfate 200 mg/mL (100 mL vial)

Model:

D-1060-2018

Lot Numbers:

58212:42

Date Ranges: Use By 06/01/2018

Product: Medroxyprogesterone 150 mg/mL (5 mL vial)

Model:

D-1061-2018

Lot Numbers:

58611:42

59099:42

58786:42

Date Ranges: Use By 06/07/2018, Use By 07/24/2018, Use By 06/24/2018

Product: Methylene Blue 10 mg/mL (1 mL syringe)

Model:

D-1062-2018

Lot Numbers:

59185:42

58471:42

58745:42

Date Ranges: Use By 07/30/2018, Use By 05/27/2018, Use By 06/10/2018

Product: Fentanyl Citrate 50 mcg/mL (2 mL syringe)

Model:

D-1063-2018

Lot Numbers:

58854:42

Date Ranges: Use By 06/28/2018

Product: Ropivacaine HCl 2 mg/mL (400 mL ON-Q Pump)

Model:

D-1064-2018

Lot Numbers:

59088:42

59159:42

Date Ranges: Use By 05/24/2018, Use By 05/30/2018

Product: Ropivacaine HCl 2 mg/mL (550 mL ON-Q Pump)

Model:

D-1065-2018

Lot Numbers:

59086:42

59163:42

Date Ranges: Use By 05/24/2018, Use By 05/30/2018

Product: Ropivacaine HCl 2 mg/mL (750 mL ON-Q Pump)

Model:

D-1066-2018

Lot Numbers:

59103:42

Date Ranges: Use By 05/25/2018

Product: Cefazolin 2 Gm/20 mL (20 mL syringe)

Model:

D-1067-2018

Lot Numbers:

58758

58760

58756

59095:42

59093:42

59091:42

Product: Glutathione 200 mg/mL (50 mL vial)

Model:

D-1068-2018

Lot Numbers:

58653:42

58773/58766

58766:42

Date Ranges: Use By 06/12/2018, Use By 06/21/2018, Use By 06/20/2018

Product: Lidocaine 3% (10 mL syringe)

Model:

D-1069-2018

Lot Numbers:

58641:42

58775:42

59077:42

Date Ranges: Use By 06/04/2018, Use By 06/16/2018, Use By 07/17/2018

Product: Glutathione 200 mg/mL 50 mL MDV

Model:

D-1070-2018

Lot Numbers:

59097:42

Date Ranges: Use By 07/23/2018

Product: Methylcobalamin 1000 mcg/mL (100 mL vial)

Model:

D-1071-2018

Lot Numbers:

58409:42

58899:42

59215:42

Date Ranges: Use By 05/21/2018, Use By 07/04/2018, Use By 08/01/2018

Product: MIC 'B' COMBO LIPOTROPIC (50 mL vial)

Model:

D-1072-2018

Lot Numbers:

58618:42

Date Ranges: Use By 06/10/2018

Product: Phenol 6% with Glycerin Inj (10 mL vial)

Model:

D-1073-2018

Lot Numbers:

58913:42

Date Ranges: Use By 06/05/2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80118

Status: Resolved

Manufacturer: Guardian Pharmacy Services

Sold By: Guardian Pharmacy Services

Manufactured In: United States

Distributed To: Texas