Amino Blend Injection, Ornithine/Arginine/Lysine/Lidocaine 75 mg/75 mg/75 mg/10 mg/mL 10 mL, Rx O...
FDA Recall #D-0444-2019 — Class II — December 17, 2018
Product Description
Amino Blend Injection, Ornithine/Arginine/Lysine/Lidocaine 75 mg/75 mg/75 mg/10 mg/mL 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Reason for Recall
Lack of sterility assurance.
Recalling Firm
Promise Pharmacy, LLC — Palm Harbor, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
158 10 ml vials
Distribution
Nationwide in the USA.
Code Information
Lots: 08302018@12 BUD: 12/24/2018; 10242018@2 BUD: 2/17/2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated