FDA recall D-0249-2017

Tri-Coast Pharmacy · Class II · drug

Product

BCAA (30 ML) (Isoleucine (L) 15 mg + Leucine (L) 10 mg+ Valine 40 mg+ Lidocaine HCL 10 mg/mL). Compounded by Tri-Coast Pharmacy.

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide

Key facts

Status
Ongoing
Initiation date
2016-11-17
Report date
2017-01-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Juno Beach, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0249-2017