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

Reason for recall

Non-Sterility

Distribution

Texas and Puerto Rico

Key facts

Status

Terminated

Initiation date

2020-10-05

Report date

2021-08-18

Termination date

2023-08-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Longview, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0717-2021