FDA recall D-0708-2021

Product

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

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-0708-2021