FDA Recall D-0717-2021

Product

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

Lot / code: 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

Quantity: 360 mL

Reason for recall

Non-Sterility

Recall record

Recall number

D-0717-2021

Classification

Class I

Status

Terminated

Voluntary or mandated

Voluntary: Firm initiated

Firm notification

Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution

Texas and Puerto Rico

Recall initiated

2020-10-05

Classified by FDA Center

2021-08-09

FDA published

2021-08-18

Terminated

2023-08-17

Recalling firm

Med Shop Total Care Inc.

Firm location

Longview, TX