Medications & Supplements/Prescription Drugs

Med Shop Total Care Inc.: Various Injectable Medications Recalled for Non-Sterility

Agency Publication Date: August 9, 2021

Summary

Med Shop Total Care Inc. has recalled 1,307 units of various injectable medications, including Bupivacaine, Fentanyl, Morphine, and Hydromorphone, due to concerns that the products are not sterile. These prescription-only medications were distributed in 21 mL to 43 mL syringes and were used for pain management and other medical treatments. The recall affects specific lots manufactured in the United States and distributed in Texas and Puerto Rico.

Risk

Injecting a drug that is not sterile can lead to life-threatening infections, including sepsis or localized abscesses at the injection site. Because these products are intended for injection into the body, the lack of sterility poses a critical health risk to patients.

What You Should Do

Check your medication syringes for the name 'Med Shop Total Care' and the specific product names including Bupivacaine, Fentanyl, Morphine, Hydromorphone, Sufentanil, or Baclofen.
Verify the Lot Numbers on your syringes. Affected lots include: 09282020 (various suffixes), 09302020 (various suffixes), 09292020 (various suffixes), 10012020 (various suffixes), and 10022020 (various suffixes).
Confirm the Beyond Use Date (BUD) on the label; affected products have dates ranging from October 23, 2020, to October 30, 2020.
Contact your healthcare provider or pharmacist immediately for guidance if you believe you have used or possess any of these affected medications.
Return any unused product to the pharmacy where it was obtained for a refund and contact Med Shop Total Care Inc. at their Longview, Texas location for further instructions.
For additional questions, 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 guidance and product refund

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

Affected Products

Product: BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML (21 mL syringe)

Model:

D-0704-2021

Lot Numbers:

09282020@94 (Exp 10/27/2020)

Date Ranges: 10/27/2020

Product: BUPIVACAINE HCL-LIORESAL PF INJECTABLE 7.5MG-1625MCG/ML (41 mL syringe)

Model:

D-0705-2021

Lot Numbers:

09282020@38 (Exp 10/29/2020)

Date Ranges: 10/29/2020

Product: FENTANYL-BUPIVACAINE HCL PF INJECTABLE 3000MCG-12MG/ML (21 mL syringe)

Model:

D-0706-2021

Lot Numbers:

09302020@67 (Exp 10/29/2020)

Date Ranges: 10/29/2020

Product: FENTANYL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 575MCG-18MG-6000MCG/ML (21 mL syringe)

Model:

D-0707-2021

Lot Numbers:

09282020@75 (Exp 10/27/2020)

Date Ranges: 10/27/2020

Product: HYDROMORPHONE HCL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE (21 mL syringe)

Model:

D-0708-2021

Lot Numbers:

10012020@42 (Exp 10/29/2020)

10012020@43 (Exp 10/29/2020)

10012020@44 (Exp 10/29/2020)

10012020@46 (Exp 10/29/2020)

09302020@16 (Exp 10/29/2020)

09302020@44 (Exp 10/29/2020)

Date Ranges: 10/29/2020

Product: HYDROMORPHONE HCL-BUPIVACAINE HCL-CLONIDINE HCL PF INJECTABLE (21 mL syringe)

Model:

D-0709-2021

Lot Numbers:

09302020@30 (Exp 10/23/2020)

10022020@14 (Exp 10/30/2020)

Date Ranges: 10/23/2020, 10/30/2020

Product: MORPHINE-BUPIVACAINE PF INJECTABLE (21 mL, 22 mL, 23 mL, 41 mL and 43 mL syringes)

Model:

D-0710-2021

Lot Numbers:

09282020@62 (Exp 10/27/2020)

09302020@25 (Exp 10/29/2020)

09292020@56

09292020@58

09292020@60

09292020@66

09292020@73

09292020@70

09292020@71

09292020@77

09302020@20

09302020@33

09302020@48

09302020@61

09302020@66

09302020@70

09302020@26 (Exp 10/29/2020)

10012020@8

10022020@20 (Exp 10/30/2020)

Date Ranges: 10/27/2020, 10/29/2020, 10/30/2020

Product: HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE (21 mL syringe)

Model:

D-0711-2021

Lot Numbers:

09282020@66 (Exp 10/27/2020)

09302020@42 (Exp 10/29/2020)

09282020@79 (Exp 10/27/2020)

09292020@32 (Exp 10/27/2020)

Date Ranges: 10/27/2020, 10/29/2020

Product: MORPHINE-HYDROMORPHONE-BUPIVACAINE PF 13MG-19MG-2MG/ML INJECTABLE (21 mL syringe)

Model:

D-0712-2021

Lot Numbers:

09292020@64 (Exp 10/28/2020)

Date Ranges: 10/28/2020

Product: MORPHINE-BUPIVACAINE-KETAMINE PF INJECTABLE (21 mL syringe)

Model:

D-0713-2021

Lot Numbers:

09302020@31 (Exp 10/28/2020)

09302020@29 (Exp 10/30/2020)

Date Ranges: 10/28/2020, 10/30/2020

Product: SUFENTANIL-BUPIVACAINE-BACLOFEN PF 25MCG-12.5MG-750MCG/ML INJECTABLE (41 mL syringe)

Model:

D-0714-2021

Lot Numbers:

09302020@47 (Exp 10/28/2020)

Date Ranges: 10/28/2020

Product: MORPHINE-BUPIVACAINE-FENTANYL PF 30MG-15MG-2000MCG/ML INJECTABLE (21 mL syringe)

Model:

D-0715-2021

Lot Numbers:

09302020@57 (Exp 10/29/2020)

Date Ranges: 10/29/2020

Product: HYDROMORPHONE HCL-BUPIVACAINE HCL-SUFENTANIL PF 25MG-9MG-110MCG/ML INJECTABLE (21 mL syringe)

Model:

D-0716-2021

Lot Numbers:

09292020@59 (Exp 10/28/2020)

Date Ranges: 10/28/2020

Product: HYDROMORPHONE HCL-BUPIVACAINE HCL PF INJECTABLE (21 and 22 mL syringes)

Model:

D-0717-2021

Lot Numbers:

09302020@40 (Exp 10/28/2020)

09292020@55 (Exp 10/27/2020)

09302020@58 (Exp 10/29/2020)

10012020@6

09302020@23

10012020@4

10012020@11 (Exp 10/29/2020)

10012020@64

10022020@22

10012020@15 (Exp 10/30/2020)

10012020@41 (Exp 10/29/2020)

09282020@92 (Exp 10/27/2020)

10012020@20 (Exp 10/30/2020)

09302020@9 (Exp 10/28/2020)

09292020@36 (Exp 10/27/2020)

09302020@11

09302020@18 (Exp 10/28/2020)

Date Ranges: 10/27/2020, 10/28/2020, 10/29/2020, 10/30/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88291

Status: Resolved

Manufacturer: Med Shop Total Care Inc.

Sold By: Med Shop Total Care Inc.; Prescribing clinics

Manufactured In: United States

Units Affected: 14 products (21 mL; 41 mL; 21 mL; 21 mL; 126 mL; 42 mL; 466 mL; 84 mL; 21 mL; 21 mL; 41 mL; 21 mL; 21 mL; 360 mL)

Distributed To: Texas, Puerto Rico

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

Check your medication syringes for the name 'Med Shop Total Care' and the specific product names including Bupivacaine, Fentanyl, Morphine, Hydromorphone, Sufentanil, or Baclofen.

Verify the Lot Numbers on your syringes. Affected lots include: 09282020 (various suffixes), 09302020 (various suffixes), 09292020 (various suffixes), 10012020 (various suffixes), and 10022020 (various suffixes).

Confirm the Beyond Use Date (BUD) on the label; affected products have dates ranging from October 23, 2020, to October 30, 2020.

Contact your healthcare provider or pharmacist immediately for guidance if you believe you have used or possess any of these affected medications.

Return any unused product to the pharmacy where it was obtained for a refund and contact Med Shop Total Care Inc. at their Longview, Texas location for further instructions.

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

Affected Products

Product: BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML (21 mL syringe)

Model:

D-0704-2021

Lot Numbers:

09282020@94 (Exp 10/27/2020)

Date Ranges: 10/27/2020

Product: BUPIVACAINE HCL-LIORESAL PF INJECTABLE 7.5MG-1625MCG/ML (41 mL syringe)

Model:

D-0705-2021

Lot Numbers:

09282020@38 (Exp 10/29/2020)

Date Ranges: 10/29/2020

Product: FENTANYL-BUPIVACAINE HCL PF INJECTABLE 3000MCG-12MG/ML (21 mL syringe)

Model:

D-0706-2021

Lot Numbers:

09302020@67 (Exp 10/29/2020)

Date Ranges: 10/29/2020

Product: FENTANYL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 575MCG-18MG-6000MCG/ML (21 mL syringe)

Model:

D-0707-2021

Lot Numbers:

09282020@75 (Exp 10/27/2020)

Date Ranges: 10/27/2020

Product: HYDROMORPHONE HCL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE (21 mL syringe)

Model:

D-0708-2021

Lot Numbers:

10012020@42 (Exp 10/29/2020)

10012020@43 (Exp 10/29/2020)

10012020@44 (Exp 10/29/2020)

10012020@46 (Exp 10/29/2020)

09302020@16 (Exp 10/29/2020)

09302020@44 (Exp 10/29/2020)

Date Ranges: 10/29/2020

Product: HYDROMORPHONE HCL-BUPIVACAINE HCL-CLONIDINE HCL PF INJECTABLE (21 mL syringe)

Model:

D-0709-2021

Lot Numbers:

09302020@30 (Exp 10/23/2020)

10022020@14 (Exp 10/30/2020)

Date Ranges: 10/23/2020, 10/30/2020

Product: MORPHINE-BUPIVACAINE PF INJECTABLE (21 mL, 22 mL, 23 mL, 41 mL and 43 mL syringes)

Model:

D-0710-2021

Lot Numbers:

09282020@62 (Exp 10/27/2020)

09302020@25 (Exp 10/29/2020)

09292020@56

09292020@58

09292020@60

09292020@66

09292020@73

09292020@70

09292020@71

09292020@77

09302020@20

09302020@33

09302020@48

09302020@61

09302020@66

09302020@70

09302020@26 (Exp 10/29/2020)

10012020@8

10022020@20 (Exp 10/30/2020)

Date Ranges: 10/27/2020, 10/29/2020, 10/30/2020

Product: HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE (21 mL syringe)

Model:

D-0711-2021

Lot Numbers:

09282020@66 (Exp 10/27/2020)

09302020@42 (Exp 10/29/2020)

09282020@79 (Exp 10/27/2020)

09292020@32 (Exp 10/27/2020)

Date Ranges: 10/27/2020, 10/29/2020

Product: MORPHINE-HYDROMORPHONE-BUPIVACAINE PF 13MG-19MG-2MG/ML INJECTABLE (21 mL syringe)

Model:

D-0712-2021

Lot Numbers:

09292020@64 (Exp 10/28/2020)

Date Ranges: 10/28/2020

Product: MORPHINE-BUPIVACAINE-KETAMINE PF INJECTABLE (21 mL syringe)

Model:

D-0713-2021

Lot Numbers:

09302020@31 (Exp 10/28/2020)

09302020@29 (Exp 10/30/2020)

Date Ranges: 10/28/2020, 10/30/2020

Product: SUFENTANIL-BUPIVACAINE-BACLOFEN PF 25MCG-12.5MG-750MCG/ML INJECTABLE (41 mL syringe)

Model:

D-0714-2021

Lot Numbers:

09302020@47 (Exp 10/28/2020)

Date Ranges: 10/28/2020

Product: MORPHINE-BUPIVACAINE-FENTANYL PF 30MG-15MG-2000MCG/ML INJECTABLE (21 mL syringe)

Model:

D-0715-2021

Lot Numbers:

09302020@57 (Exp 10/29/2020)

Date Ranges: 10/29/2020

Product: HYDROMORPHONE HCL-BUPIVACAINE HCL-SUFENTANIL PF 25MG-9MG-110MCG/ML INJECTABLE (21 mL syringe)

Model:

D-0716-2021

Lot Numbers:

09292020@59 (Exp 10/28/2020)

Date Ranges: 10/28/2020

Product: HYDROMORPHONE HCL-BUPIVACAINE HCL PF INJECTABLE (21 and 22 mL syringes)

Model:

D-0717-2021

Lot Numbers:

09302020@40 (Exp 10/28/2020)

09292020@55 (Exp 10/27/2020)

09302020@58 (Exp 10/29/2020)

10012020@6

09302020@23

10012020@4

10012020@11 (Exp 10/29/2020)

10012020@64

10022020@22

10012020@15 (Exp 10/30/2020)

10012020@41 (Exp 10/29/2020)

09282020@92 (Exp 10/27/2020)

10012020@20 (Exp 10/30/2020)

09302020@9 (Exp 10/28/2020)

09292020@36 (Exp 10/27/2020)

09302020@11

09302020@18 (Exp 10/28/2020)

Date Ranges: 10/27/2020, 10/28/2020, 10/29/2020, 10/30/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88291

Status: Resolved

Manufacturer: Med Shop Total Care Inc.

Sold By: Med Shop Total Care Inc.; Prescribing clinics

Manufactured In: United States

Units Affected: 14 products (21 mL; 41 mL; 21 mL; 21 mL; 126 mL; 42 mL; 466 mL; 84 mL; 21 mL; 21 mL; 41 mL; 21 mL; 21 mL; 360 mL)

Distributed To: Texas, Puerto Rico