September 2020 FDA Recall Drug by Pd-rx Pharmaceuticals, Inc.
D-0005-2021 - CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured under the same conditions as products found to be sub-potent.

This Class II drug recall was voluntarily initiated by Pd-rx Pharmaceuticals, Inc. on September 17, 2020 for the product Drug. The FDA reported the reason for recall as cgmp deviations; repackaged product was recalled by the manufacturer because it was manufactured under the same conditions as products found to be sub-potent.. The product was distributed in AZ, OK and the recall is currently terminated.

Recall Number: D-0005-2021

Reason for Recall
CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured under the same conditions as products found to be sub-potent.
Initiated
09-17-2020
Reported
10-14-2020
Quantity
20 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86533
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
PD-Rx Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
AZ, OK
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-05-2021
Product Description About Product Description
Full technical description of the product.
Nature-Throid 1 GR (65 mg), Each Tablet Contains: Thyroid USP 1 GR (65 mg), Liothyronine (T3) 9 mcg, Levothyroxine (T4) 38 mcg, 100 Tablets per bottle, Rx Only, Pkg By PD-Rx Pharmaceuticals Incorporated, Oklahoma City, OK 73127, NDC 43063-819-01.

Batch or Lot Expiration Information

Lot# : J18C68 Exp. 10/31/20