Multi-event October 2020 FDA Recall Drug by Med Shop Total Care Inc.

This Multi-event Class I drug recall was voluntarily initiated by Med Shop Total Care Inc. on October 5, 2020 for the product Drug. The FDA reported the reason for recall as non-sterility. The product was distributed in Texas and Puerto Rico and the recall is currently terminated.

Reported Recall Events

Recall Number: D-0709-2021

Reason for Recall
Non-Sterility
Initiated
10-05-2020
Reported
08-18-2021
Quantity
42 mL

Recall Profile & Regulatory Data

Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Med Shop Total Care Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Texas and Puerto Rico
HYDROMORPHONE HCL-BUPIVACAINE HCL-CLONIDINE HCL PF INJECTABLE 21 mL syringes in two strengths: a) 20MG-20MG-60MCG/ML INJECTABLE, b) 5MG-5MG-100MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

Batch or Lot Expiration Information

Lot# : a) 09302020@30, BUD 10/23/2020, b) 10022020@14, BUD 10/30/2020

Recall Number: D-0711-2021

Reason for Recall
Non-Sterility
Initiated
10-05-2020
Reported
08-18-2021
Quantity
84 mL

Recall Profile & Regulatory Data

Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Med Shop Total Care Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Texas and Puerto Rico
HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in various strengths, a)10MG-20MG-100MCG/ML, b) 20MG-10MG-450MCG/ML, c) 13.3MG-3MG-3000MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

Batch or Lot Expiration Information

Lot# : a) 09282020@66, BUD 10/27/2020, 09302020@42, BUD 10/29/2020, b) 09282020@79, c) 09292020@32, BUD 10/27/2020 09282020@66 09302020@42 09282020@79 09292020@32 10/27/2020 10/29/2020 10/27/2020 10/27/2020

Recall Number: D-0712-2021

Reason for Recall
Non-Sterility
Initiated
10-05-2020
Reported
08-18-2021
Quantity
21 mL

Recall Profile & Regulatory Data

Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Med Shop Total Care Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Texas and Puerto Rico
MORPHINE-HYDROMORPHONE-BUPIVACAINE PF 13MG-19MG-2MG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop 470 E. Loop 281 Longview, TX 75605

Batch or Lot Expiration Information

Lot# : 09292020@64, BUD 10/28/2020

Recall Number: D-0715-2021

Reason for Recall
Non-Sterility
Initiated
10-05-2020
Reported
08-18-2021
Quantity
21 mL

Recall Profile & Regulatory Data

Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Med Shop Total Care Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Texas and Puerto Rico
MORPHINE-BUPIVACAINE-FENTANYL PF 30MG-15MG-2000MCG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

Batch or Lot Expiration Information

Lot# : 09302020@57 BUD 10/29/2020

Recall Number: D-0704-2021

Reason for Recall
Non-Sterility
Initiated
10-05-2020
Reported
08-18-2021
Quantity
21 mL

Recall Profile & Regulatory Data

Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Med Shop Total Care Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Texas and Puerto Rico
BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

Batch or Lot Expiration Information

Lot# : 09282020@94 BUD: 10/27/2020

Recall Number: D-0708-2021

Reason for Recall
Non-Sterility
Initiated
10-05-2020
Reported
08-18-2021
Quantity
126 mL

Recall Profile & Regulatory Data

Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Med Shop Total Care Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Texas and Puerto Rico
HYDROMORPHONE HCL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 21 mL syringes in various strengths: a) 2.5MG-1.25MG-0.5MCG/ML, b) 10MG-5MG-10MCG/ML, c) 2MG-1MG-10MCG/ML, d) 10MG-5MG-10MCG/ML, e) 15MG-5MG-2000MCG/ML, f) 8MG-10MG-400MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

Batch or Lot Expiration Information

Lot# : a)10012020@42, b) 10012020@43, c) 10012020@44, d) 10012020@46, e) 09302020@16, f) 09302020@44, BUD 10/29/2020

Recall Number: D-0706-2021

Reason for Recall
Non-Sterility
Initiated
10-05-2020
Reported
08-18-2021
Quantity
21 mL

Recall Profile & Regulatory Data

Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Med Shop Total Care Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Texas and Puerto Rico
FENTANYL-BUPIVACAINE HCL PF INJECTABLE 3000MCG-12MG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

Batch or Lot Expiration Information

Lot# : 09302020@67 BUD: 10/29/2020

Recall Number: D-0717-2021

Reason for Recall
Non-Sterility
Initiated
10-05-2020
Reported
08-18-2021
Quantity
360 mL

Recall Profile & Regulatory Data

Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Med Shop Total Care Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Texas and Puerto Rico
HYDROMORPHONE HCL-BUPIVACAINE HCL PF INJECTABLE 21 and 22 mL syringes in various strengths: a) 0.5MG-5MG/ML, b) 2MG-35MG/ML, c) 25MG-15MG/ML, d) 6MG-1.5MG/ML, e) 3MG-3MG/ML, f) 5MG-15MG/ML, g)12MG-8MG/ML, h)2MG-2MG/ML, i) 30MG-30MG/ML, j) 8MG-20MG/ML, k) 20MG-10MG/ML, l)50MG-3.5MG/ML, m) 10MG-30MG/ML, n)15MG-1.6MG/ML, o) 20MG-30MG/ML, p)15MG-6MG/ML, q)15MG-27MG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

Batch or Lot Expiration Information

Lot# : a) 09302020@40, BUD 10/28/2020, b) 09292020@55, BUD 10/27/2020, c) 09302020@58, BUD 10/29/2020, d) 10012020@6, e) 09302020@23, f)10012020@4, g) 10012020@11 BUD 10/29/2020, h) 10012020@64, i)10022020@22, j) 10012020@15 BUD 10/30/2020, k) 10012020@41 BUD 10/29/2020, l) 09282020@92, BUD 10/27/2020, m)10012020@20 BUD 10/30/2020, n) 09302020@9, BUD 10/28/2020, o) 09292020@36, BUD 10/27/2020, p) 09302020@11, q) 09302020@18, BUD 10/28/2020

Recall Number: D-0713-2021

Reason for Recall
Non-Sterility
Initiated
10-05-2020
Reported
08-18-2021
Quantity
21 mL

Recall Profile & Regulatory Data

Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Med Shop Total Care Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Texas and Puerto Rico
MORPHINE-BUPIVACAINE-KETAMINE PF INJECTABLE 21 mL syringe in two strengths: a) 5MG-25MG-5MG/ML, b) 1MG-2MG-100MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

Batch or Lot Expiration Information

Lot# : 09302020@31, BUD 10/28/2020, b) 09302020@29, BUD 10/30/2020

Recall Number: D-0710-2021

Reason for Recall
Non-Sterility
Initiated
10-05-2020
Reported
08-18-2021
Quantity
466 mL

Recall Profile & Regulatory Data

Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Med Shop Total Care Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Texas and Puerto Rico
MORPHINE-BUPIVACAINE PF INJECTABLE 21 mL, 22 mL, 23 mL, 41 mL and 43 mL syringes in various strengths: a) 20MG/ML-40MG/ML, b) 15MG-30MG/ML, c) 5MG/ML-20MG/ML, d) 2MG-30MG/ML, e) 20MG-5MG/ML, f) 15MG-5MG/ML, g) 5MG-2MG/ML, h) 5MG-11MG/ML, i) 20MG-6MG/ML, j) 10MG-10MG/ML, k) 6MG-4.8MG/ML, l) 30MG-10MG/ML, m) 5MG-4MG/ML, n) 10MG/ML-20MG/ML, o) 40MG-5MG/ML, p) 20MG-20MG/ML, q) 30MG-20MG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

Batch or Lot Expiration Information

Lot# : a) 09282020@62, BUD 10/27/2020, 09302020@25, BUD 10/29/2020, b) 09292020@56, c) 09292020@58, d)09292020@60, e) 09292020@66, 09292020@73, f) 09292020@70, g) 09292020@71, h) 09292020@77, i) 09302020@20 j) 09302020@33, k) 09302020@48, l) 09302020@61, m) 09302020@66, n) 09302020@70, o) 09302020@26, BUD 10/29/2020, p) 10012020@8, q) 10022020@20, BUD 10/30/2020

Recall Number: D-0716-2021

Reason for Recall
Non-Sterility
Initiated
10-05-2020
Reported
08-18-2021
Quantity
21 mL

Recall Profile & Regulatory Data

Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Med Shop Total Care Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Texas and Puerto Rico
HYDROMORPHONE HCL-BUPIVACAINE HCL-SUFENTANIL PF 25MG-9MG-110MCG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

Batch or Lot Expiration Information

Lot# : 09292020@59 BUD 10/28/2020

Recall Number: D-0707-2021

Reason for Recall
Non-Sterility
Initiated
10-05-2020
Reported
08-18-2021
Quantity
21 mL

Recall Profile & Regulatory Data

Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Med Shop Total Care Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Texas and Puerto Rico
FENTANYL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 575MCG-18MG-6000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

Batch or Lot Expiration Information

Lot# : 09282020@75 BUD: 10/27/2020

Recall Number: D-0705-2021

Reason for Recall
Non-Sterility
Initiated
10-05-2020
Reported
08-18-2021
Quantity
41 mL

Recall Profile & Regulatory Data

Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Med Shop Total Care Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Texas and Puerto Rico
BUPIVACAINE HCL-LIORESAL PF INJECTABLE 7.5MG-1625MCG/ML, 41 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

Batch or Lot Expiration Information

Lot# : 09282020@38 BUD: 10/29/2020

Recall Number: D-0714-2021

Reason for Recall
Non-Sterility
Initiated
10-05-2020
Reported
08-18-2021
Quantity
41 mL

Recall Profile & Regulatory Data

Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Med Shop Total Care Inc.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Texas and Puerto Rico
SUFENTANIL-BUPIVACAINE-BACLOFEN PF 25MCG-12.5MG-750MCG/ML INJECTABLE 41 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

Batch or Lot Expiration Information

Lot# : 09302020@47 BUD 10/28/2020