BCAA (30 ML) (Isoleucine (L) 15 mg + Leucine (L) 10 mg+ Valine 40 mg+ Lidocaine HCL 10 mg/mL). C...
FDA Recall #D-0249-2017 — Class II — November 17, 2016
Product Description
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
Recalling Firm
Tri-Coast Pharmacy — Juno Beach, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
265 vials
Distribution
Nationwide
Code Information
Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 07222016A (01/18/2017), 08162016C (02/12/2017), 08042016A (01/31/2017), 11012016I (04/30/2017), 10172016B (02/28/2017).
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated