FDA recall D-0251-2015

Abrams Royal Pharmacy · Class I · drug

Product

Lidocaine 18.18 mg/mL/Bupivacaine 2.27 mg/mL/Epinephrine 0.0022 mg/mL/Hyaluronidase13.64 u/mL, supplied in 11 mL Sterile Syringes, Rx only, Compounded med, Single use only, (Red Block) ABRAMS ROYAL Compounding Pharmacy, Dallas, TX

Reason for recall

Non-Sterility

Distribution

Texas

Key facts

Status: Terminated
Initiation date: 2013-04-19
Report date: 2014-11-26
Termination date: 2016-10-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Dallas, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0251-2015