PrednisoLONE 10 mg Tablet, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Rat...

FDA Recall #D-0187-2018 — Class II — November 16, 2017

Recall #D-0187-2018 Date: November 16, 2017 Classification: Class II Status: Terminated

Product Description

PrednisoLONE 10 mg Tablet, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.

Reason for Recall

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

Recalling Firm

KRS Global Biotechnology, Inc — Boca Raton, FL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

3,000 tablets

Distribution

Nationwide in the USA, Bermuda, and New Zealand

Code Information

Lot: 07172017@40 BUD: 1/13/2018

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated