Medications & Supplements/Prescription Drugs

Apollo Care Injectable Medications and IV Bags Recalled for Sterility Concerns

Agency Publication Date: May 18, 2023

Summary

Apollo Care, LLC is voluntarily recalling 15,524 units of various injectable medications and IV bags, including Phenylephrine, Succinylcholine, Fentanyl, Ketamine, Vancomycin, and Norepinephrine. The medications were recalled because they may not be sterile, meaning they could be contaminated with bacteria or other germs. These drugs are distributed in single-use syringes and IV bags for clinical use in Missouri. No injuries have been reported to date, but the manufacturer initiated the recall after identifying concerns with the sterility assurance of these products.

Risk

Administering a medication that is not sterile directly into a patient's vein poses a significant risk of serious infection. Patients receiving these treatments could develop systemic illnesses if the products are contaminated with pathogens.

What You Should Do

This recall affects various injectable medications and IV bags produced by Apollo Care, LLC, including Phenylephrine, Succinylcholine, Fentanyl, Ketamine, Vancomycin, and Norepinephrine.
Identify affected products by checking the label for the manufacturer name 'Apollo Care, LLC' and the specific NDC and lot numbers. See the Affected Products section below for the full list of affected codes.
Stop using the recalled product immediately and quarantine all remaining inventory to prevent further use.
Contact Apollo Care, LLC or your distributor to arrange for the return of the affected medications.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: PHENYLephrine HCl Injection, 1 mg per 10 mL (100 mcg/mL), Single-Use Syringe

Variants: 1 mg per 10 mL, Solution for IV Use Only

Lot Numbers:

AC-016606 (Exp. Date 05/06/2023)

AC-016636 (Exp. Date 07/09/2023)

AC-016643 (Exp. Date 07/31/2023)

NDC:

71170-010-10

Apollo Care, LLC, 3801 Mojae Ct., Suite 101, Columbia, MO 65202.

Product: Succinylcholine Cl Injection, 100 mg per 5 mL (20 mg/mL), Single-Use Syringe

Variants: 100 mg per 5 mL, Rx only

Lot Numbers:

AC-016607 (Exp. Date 05/09/2023)

NDC:

71170-020-05

Product: FentaNYL 50 mcg/mL (2,500mcg Total Dose), 50 mL Syringe

Variants: 50 mcg/mL, Rx Only

Lot Numbers:

AC-016624 (Exp. Date 06/10/2023)

NDC:

71170-910-25

Product: Ketamine Injection, 50 mg per 5 mL (10 mg/mL), Single-Use Syringe

Variants: 50 mg per 5 mL, Rx only

Lot Numbers:

AC-016627 (Exp. Date 06/17/2023)

AC-016635 (Exp. Date 07/08/2023)

AC-016662 (Exp. Date 09/30/2023)

NDC:

71170-050-05

Product: VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection

Variants: 1.5g in 500 mL, Rx only

Lot Numbers:

AC-016629 (Exp. Date 05/13/2023)

AC-016646 (Exp. Date 06/24/2023)

NDC:

71170-185-50

Product: Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection

Variants: 8 mg in 250 mL, Rx Only

Lot Numbers:

AC-016631 (Exp. Date 05/29/2023)

AC-016655 (Exp. Date 08/07/2023)

NDC:

71170-550-25

Product: VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection (NDC -284)

Variants: 1.25g in 250 mL, Rx Only

Lot Numbers:

AC-016647 (Exp. Date 06/28/2023)

NDC:

71170-284-25

Product: VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection (NDC -264)

Variants: 1.25g in 250 mL, Rx Only

Lot Numbers:

AC-016647 (Exp. Date 06/28/2023)

NDC:

71170-264-25

Product: VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection

Variants: 1 g in 250 mL, Rx Only

Lot Numbers:

AC-016641 (Exp. Date 06/03/2023)

AC-016653 (Exp. Date 07/26/2023)

NDC:

71170-254-25

Product: VANComycin 1.75 g added to 500 mL of 0.9% Sodium Chloride Injection

Variants: 1.75 g in 500 mL, Rx Only

Lot Numbers:

AC-016648 (Exp. Date 07/01/2023)

NDC:

71170-194-50

Product: VANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection

Variants: 2g in 500 mL, Rx Only

Lot Numbers:

AC-016638 (Exp. Date 05/27/2023)

NDC:

71170-204-50

Product: VANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection

Variants: 2.5 g in 500 mL, Rx Only

Lot Numbers:

AC-016649 (Exp. Date 07/01/2023)

NDC:

71170-224-50

Product: Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection

Variants: 4 mg in 250 mL, Rx Only

Lot Numbers:

AC-016640 (Exp. Date 06/16/2023)

AC-016670 (Exp. Date 08/29/2023)

NDC:

71170-500-25

Product: VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection

Variants: 750mg in 250 mL, Rx Only

Lot Numbers:

AC-016632 (Exp. Date 05/24/2023)

NDC:

71170-255-25

Product: FentaNYL 500 mcg and Ropivacaine HCL 250 mg in 250 mL 0.9% Sodium Chloride Injection

Variants: 500 mcg / 250 mg in 250 mL, Rx Only

Lot Numbers:

AC-016644 (Exp. Date 05/08/2023)

AC-016659 (Exp. Date 09/26/2023)

NDC:

71170-950-25

Product: VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection

Variants: 1.5g in 250 mL, Rx only

Lot Numbers:

AC-016633 (Exp. Date 05/24/2023)

AC-016651 (Exp. Date 07/22/2023)

NDC:

71170-184-25

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92348

Status: Active

Manufacturer: Apollo Care, LLC

Sold By: Hospitals; Infusion Centers; Surgical Centers

Manufactured In: United States

Units Affected: 16 products (2265 syringes; 90 syringes; 790 syringes; 2040 syringes; 2040 bags; 1617 bags; 1113 bags; 1113 bags; 1622 bags; 240 bags; 413 bags; 54 bags; 682 bags; 491 bags; 308 bags; 646 bags)

Distributed To: Missouri

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

This recall affects various injectable medications and IV bags produced by Apollo Care, LLC, including Phenylephrine, Succinylcholine, Fentanyl, Ketamine, Vancomycin, and Norepinephrine.

Identify affected products by checking the label for the manufacturer name 'Apollo Care, LLC' and the specific NDC and lot numbers. See the Affected Products section below for the full list of affected codes.

Stop using the recalled product immediately and quarantine all remaining inventory to prevent further use.

Contact Apollo Care, LLC or your distributor to arrange for the return of the affected medications.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Affected Products

Product: PHENYLephrine HCl Injection, 1 mg per 10 mL (100 mcg/mL), Single-Use Syringe

Variants: 1 mg per 10 mL, Solution for IV Use Only

Lot Numbers:

AC-016606 (Exp. Date 05/06/2023)

AC-016636 (Exp. Date 07/09/2023)

AC-016643 (Exp. Date 07/31/2023)

NDC:

71170-010-10

Apollo Care, LLC, 3801 Mojae Ct., Suite 101, Columbia, MO 65202.

Product: Succinylcholine Cl Injection, 100 mg per 5 mL (20 mg/mL), Single-Use Syringe

Variants: 100 mg per 5 mL, Rx only

Lot Numbers:

AC-016607 (Exp. Date 05/09/2023)

NDC:

71170-020-05

Product: FentaNYL 50 mcg/mL (2,500mcg Total Dose), 50 mL Syringe

Variants: 50 mcg/mL, Rx Only

Lot Numbers:

AC-016624 (Exp. Date 06/10/2023)

NDC:

71170-910-25

Product: Ketamine Injection, 50 mg per 5 mL (10 mg/mL), Single-Use Syringe

Variants: 50 mg per 5 mL, Rx only

Lot Numbers:

AC-016627 (Exp. Date 06/17/2023)

AC-016635 (Exp. Date 07/08/2023)

AC-016662 (Exp. Date 09/30/2023)

NDC:

71170-050-05

Product: VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection

Variants: 1.5g in 500 mL, Rx only

Lot Numbers:

AC-016629 (Exp. Date 05/13/2023)

AC-016646 (Exp. Date 06/24/2023)

NDC:

71170-185-50

Product: Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection

Variants: 8 mg in 250 mL, Rx Only

Lot Numbers:

AC-016631 (Exp. Date 05/29/2023)

AC-016655 (Exp. Date 08/07/2023)

NDC:

71170-550-25

Product: VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection (NDC -284)

Variants: 1.25g in 250 mL, Rx Only

Lot Numbers:

AC-016647 (Exp. Date 06/28/2023)

NDC:

71170-284-25

Product: VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection (NDC -264)

Variants: 1.25g in 250 mL, Rx Only

Lot Numbers:

AC-016647 (Exp. Date 06/28/2023)

NDC:

71170-264-25

Product: VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection

Variants: 1 g in 250 mL, Rx Only

Lot Numbers:

AC-016641 (Exp. Date 06/03/2023)

AC-016653 (Exp. Date 07/26/2023)

NDC:

71170-254-25

Product: VANComycin 1.75 g added to 500 mL of 0.9% Sodium Chloride Injection

Variants: 1.75 g in 500 mL, Rx Only

Lot Numbers:

AC-016648 (Exp. Date 07/01/2023)

NDC:

71170-194-50

Product: VANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection

Variants: 2g in 500 mL, Rx Only

Lot Numbers:

AC-016638 (Exp. Date 05/27/2023)

NDC:

71170-204-50

Product: VANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection

Variants: 2.5 g in 500 mL, Rx Only

Lot Numbers:

AC-016649 (Exp. Date 07/01/2023)

NDC:

71170-224-50

Product: Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection

Variants: 4 mg in 250 mL, Rx Only

Lot Numbers:

AC-016640 (Exp. Date 06/16/2023)

AC-016670 (Exp. Date 08/29/2023)

NDC:

71170-500-25

Product: VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection

Variants: 750mg in 250 mL, Rx Only

Lot Numbers:

AC-016632 (Exp. Date 05/24/2023)

NDC:

71170-255-25

Product: FentaNYL 500 mcg and Ropivacaine HCL 250 mg in 250 mL 0.9% Sodium Chloride Injection

Variants: 500 mcg / 250 mg in 250 mL, Rx Only

Lot Numbers:

AC-016644 (Exp. Date 05/08/2023)

AC-016659 (Exp. Date 09/26/2023)

NDC:

71170-950-25

Product: VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection

Variants: 1.5g in 250 mL, Rx only

Lot Numbers:

AC-016633 (Exp. Date 05/24/2023)

AC-016651 (Exp. Date 07/22/2023)

NDC:

71170-184-25

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92348

Status: Active

Manufacturer: Apollo Care, LLC

Sold By: Hospitals; Infusion Centers; Surgical Centers

Manufactured In: United States

Distributed To: Missouri