D-0444-2019 Class II Terminated

Recalled by Promise Pharmacy, LLC — Palm Harbor, FL

Recall Details

Product Type
Drugs
Report Date
February 20, 2019
Initiation Date
December 17, 2018
Termination Date
March 30, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
158 10 ml vials

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.

Distribution Pattern

Nationwide in the USA.

Code Information

Lots: 08302018@12 BUD: 12/24/2018; 10242018@2 BUD: 2/17/2019