Medications & Supplements/Prescription Drugs

Family Pharmacy of Statesville Injectable Drugs Recalled for Sterility Concerns

Agency Publication Date: March 17, 2022

Summary

Family Pharmacy of Statesville is recalling 36 units of various injectable and infusion medications due to a lack of assurance of sterility. The recall includes prescription drugs such as Hydromorphone, Morphine Sulfate, Fentanyl, and Ketamine, which are used for pain management and anesthesia. These products were distributed in various forms, including infusion bags, vials, and syringes. This recall was initiated because the pharmacy could not guarantee the medications were sterile, and no injuries have been reported to date.

Risk

Medications that are intended to be sterile but lack sterility assurance pose a high risk of causing serious, potentially life-threatening infections if administered to a patient. Because these drugs are injected or infused directly into the body, any contamination can lead to systemic illness.

What You Should Do

This recall affects various injectable and infusion medications from Family Pharmacy of Statesville, including Hydromorphone HCl, Trimix, Vancomycin, Morphine Sulfate, Ketamine, Lorazepam, Methylcobalamin, and Fentanyl. See the Affected Products section below for the full list of affected codes.
Stop using the recalled medications immediately.
Contact the manufacturer, Family Pharmacy of Statesville, directly to arrange for the return of any remaining product.
If you have health concerns or believe you have experienced a reaction to these medications, contact your healthcare provider or pharmacist immediately.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

Other Action

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

How to: Patients and healthcare facilities should stop using the recalled sterile products immediately. Contact Family Pharmacy of Statesville to arrange for the return of any unused product.

Affected Products

Product: Hydromorphone HCl 2 mg/mL Infusion (250 mL bags)

Variants: 2 mg/mL, Infusion Bag

Lot Numbers:

07212020@4 (BUD: 10/19/2020)

07212020@4 (BUD: 10/30/2020)

Recall #: D-0656-2022

Product: Hydromorphone HCl 1 mg/mL Infusion (250 mL bags)

Variants: 1 mg/mL, Infusion Bag

Lot Numbers:

07272020@2 (BUD: 10/25/2020)

07302020@1 (BUD: 10/28/2020)

08012020@1 (BUD: 10/30/2020)

Recall #: D-0657-2022

Product: Hydromorphone HCl 5 mg/mL Infusion (250 mL bags)

Variants: 5 mg/mL, Infusion Bag

Lot Numbers:

07292020@7 (BUD: 8/12/2020)

Recall #: D-0658-2022

Product: Hydromorphone HCl 0.1 mg/mL Infusion (1000 mL bags)

Variants: 0.1 mg/mL, Infusion Bag

Lot Numbers:

08022020@1 (BUD: 8/17/2020)

Recall #: D-0659-2022

Product: Trimix (Alprostadil/Papaverine/Phentolamine) 20 mcg/30 mg/0.5 mg Injectable (5 mL vials)

Variants: 20 mcg/30 mg/0.5 mg, Injectable Vial

Lot Numbers:

07212020@ (BUD: 9/4/2020)

Recall #: D-0660-2022

Product: Trimix (Alprostadil/Papaverine/Phentolamine) 10 mcg/20 mg/1 mg Injectable (5 mL vials)

Variants: 10 mcg/20 mg/1 mg, Injectable Vial

Lot Numbers:

07232020@1 (BUD: 9/6/2020)

07282020@1 (BUD: 9/11/2020)

07282020@2 (BUD: 9/11/2020)

Recall #: D-0661-2022

Product: Vancomycin 14 mg/mL Fortified Ophthalmic Solution (5 mL bottles)

Variants: 14 mg/mL, Ophthalmic Solution

Lot Numbers:

07312020@2 (BUD: 9/14/2020)

Recall #: D-0662-2022

Product: Morphine Sulfate 6 mg/mL Infusion (250 mL bags)

Variants: 6 mg/mL, Infusion Bag

Lot Numbers:

07212020@3 (BUD: 10/19/2020)

07292020@2 (BUD: 10/27/2020)

Recall #: D-0663-2022

Product: Ketamine 50 mg Infusion (LV 1) Solution (250 mL bags)

Variants: 50 mg, Infusion Bag

Lot Numbers:

07212020@1 (BUD: 8/4/2020)

07232020@2 (BUD: 8/6/2020)

07302020@2 (BUD: 8/13/2020)

Recall #: D-0664-2022

Product: Lorazepam 1 mg/mL Infusion Solution (250 mL bags)

Variants: 1 mg/mL, Infusion Bag

Lot Numbers:

07312020@6 (BUD: 8/7/2020)

Recall #: D-0665-2022

Product: Methylcobalamin 1 mg/mL Injectable (1 mL syringes)

Variants: 1 mg/mL, Injectable Syringe

Lot Numbers:

07282020@3 (BUD: 8/11/2020)

Recall #: D-0666-2022

Product: Fentanyl 150 mcg/mL Infusion Solution (250 mL bags)

Variants: 150 mcg/mL, Infusion Bag

Lot Numbers:

07312020@5 (BUD: 8/14/2020)

Recall #: D-0667-2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89773

Status: Resolved

Manufacturer: Family Pharmacy of Statesville

Sold By: Family Pharmacy of Statesville

Manufactured In: United States

Units Affected: 12 products (2 bags; 4 bags; 1 bag; 1 bag; 2 vials; 5 vials; 3 bottles; 8 bags; 3 bags; 1 bag; 5 syringes; 1 bag)

Distributed To: North Carolina

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 and infusion medications from Family Pharmacy of Statesville, including Hydromorphone HCl, Trimix, Vancomycin, Morphine Sulfate, Ketamine, Lorazepam, Methylcobalamin, and Fentanyl. See the Affected Products section below for the full list of affected codes.

Stop using the recalled medications immediately.

Contact the manufacturer, Family Pharmacy of Statesville, directly to arrange for the return of any remaining product.

If you have health concerns or believe you have experienced a reaction to these medications, contact your healthcare provider or pharmacist immediately.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

Other Action

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

How to: Patients and healthcare facilities should stop using the recalled sterile products immediately. Contact Family Pharmacy of Statesville to arrange for the return of any unused product.

Affected Products

Product: Hydromorphone HCl 2 mg/mL Infusion (250 mL bags)

Variants: 2 mg/mL, Infusion Bag

Lot Numbers:

07212020@4 (BUD: 10/19/2020)

07212020@4 (BUD: 10/30/2020)

Recall #: D-0656-2022

Product: Hydromorphone HCl 1 mg/mL Infusion (250 mL bags)

Variants: 1 mg/mL, Infusion Bag

Lot Numbers:

07272020@2 (BUD: 10/25/2020)

07302020@1 (BUD: 10/28/2020)

08012020@1 (BUD: 10/30/2020)

Recall #: D-0657-2022

Product: Hydromorphone HCl 5 mg/mL Infusion (250 mL bags)

Variants: 5 mg/mL, Infusion Bag

Lot Numbers:

07292020@7 (BUD: 8/12/2020)

Recall #: D-0658-2022

Product: Hydromorphone HCl 0.1 mg/mL Infusion (1000 mL bags)

Variants: 0.1 mg/mL, Infusion Bag

Lot Numbers:

08022020@1 (BUD: 8/17/2020)

Recall #: D-0659-2022

Product: Trimix (Alprostadil/Papaverine/Phentolamine) 20 mcg/30 mg/0.5 mg Injectable (5 mL vials)

Variants: 20 mcg/30 mg/0.5 mg, Injectable Vial

Lot Numbers:

07212020@ (BUD: 9/4/2020)

Recall #: D-0660-2022

Product: Trimix (Alprostadil/Papaverine/Phentolamine) 10 mcg/20 mg/1 mg Injectable (5 mL vials)

Variants: 10 mcg/20 mg/1 mg, Injectable Vial

Lot Numbers:

07232020@1 (BUD: 9/6/2020)

07282020@1 (BUD: 9/11/2020)

07282020@2 (BUD: 9/11/2020)

Recall #: D-0661-2022

Product: Vancomycin 14 mg/mL Fortified Ophthalmic Solution (5 mL bottles)

Variants: 14 mg/mL, Ophthalmic Solution

Lot Numbers:

07312020@2 (BUD: 9/14/2020)

Recall #: D-0662-2022

Product: Morphine Sulfate 6 mg/mL Infusion (250 mL bags)

Variants: 6 mg/mL, Infusion Bag

Lot Numbers:

07212020@3 (BUD: 10/19/2020)

07292020@2 (BUD: 10/27/2020)

Recall #: D-0663-2022

Product: Ketamine 50 mg Infusion (LV 1) Solution (250 mL bags)

Variants: 50 mg, Infusion Bag

Lot Numbers:

07212020@1 (BUD: 8/4/2020)

07232020@2 (BUD: 8/6/2020)

07302020@2 (BUD: 8/13/2020)

Recall #: D-0664-2022

Product: Lorazepam 1 mg/mL Infusion Solution (250 mL bags)

Variants: 1 mg/mL, Infusion Bag

Lot Numbers:

07312020@6 (BUD: 8/7/2020)

Recall #: D-0665-2022

Product: Methylcobalamin 1 mg/mL Injectable (1 mL syringes)

Variants: 1 mg/mL, Injectable Syringe

Lot Numbers:

07282020@3 (BUD: 8/11/2020)

Recall #: D-0666-2022

Product: Fentanyl 150 mcg/mL Infusion Solution (250 mL bags)

Variants: 150 mcg/mL, Infusion Bag

Lot Numbers:

07312020@5 (BUD: 8/14/2020)

Recall #: D-0667-2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89773

Status: Resolved

Manufacturer: Family Pharmacy of Statesville

Sold By: Family Pharmacy of Statesville

Manufactured In: United States

Units Affected: 12 products (2 bags; 4 bags; 1 bag; 1 bag; 2 vials; 5 vials; 3 bottles; 8 bags; 3 bags; 1 bag; 5 syringes; 1 bag)

Distributed To: North Carolina