Recall Register

Drug recall: Nature-Throid 1 GR (65 mg), Each Tablet Contains: Thyroid USP 1 GR (65 mg), Liothyronine (T3) 9 mcg, Levothyroxine…

Class II FDA enforcement event 86533. Recall start date: . Status in the FDA record: Terminated. Termination date: .

Reason for recall, in the words of FDA

CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured under the same conditions as products found to be sub-potent.

Class II, in the words of FDA

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

PD-Rx Pharmaceuticals, Inc. started this drug recall on 17 Sep 2020. The firm address in the FDA record is in Oklahoma City, OK. FDA put the recall in Class II. FDA event 86533 has 1 product record. The first FDA enforcement report date is 14 Oct 2020. The record gives the status Terminated, with the termination date 5 Nov 2021.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Distribution

In the words of FDA.

AZ, OK

Recalling firm

PD-Rx Pharmaceuticals, Inc., Oklahoma City, OK.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 86533: product records
Recall numberProductQuantityClassStatusReport date
D-0005-2021Nature-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 43063-819-01.20 bottlesClass IITerminated14 Oct 2020

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2020
342
Share of these events in Class II
64%
Product records in this event
1Median of the firm: 1
Events of the firm on the register
17

Other events of the firm

Other FDA enforcement events of PD-Rx Pharmaceuticals, Inc.
InitiatedProduct (first record)TypeClassRecords
4 Dec 2024DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDCDrugClass II1
6 Apr 2023Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx PhaDrugClass II5
6 Jun 2022Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc.DrugClass II3
6 Oct 2020metformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30; b) 60 tablets NDC: 72789-009-60; c) 90 tablets NDC: 72789-009-DrugClass II2
5 Jun 2020metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); c) 90 tablets (NDC 72789-00DrugClass II1
5 Jun 2020metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets (NDC: 43063-428-60); c) 90 tablets (NDC: 4DrugClass II1
15 May 2020Doxycycline Hyclate tablets USP, 100 mg, packaged in bottles a) 6-count (NDC 55289-866-06), b) 10-count (NDC 55289-866-1DrugClass II1
10 Jan 2020ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14); b) 30-count bottles (NDC 43063-84DrugClass II1
8 Mar 2019Losartan Potassium USP, 50 mg, RX Only, Pkg By PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 60 Tablets DrugClass II1
7 Aug 2018Doxycycline Hyclate USP Tablets, 100 mg packaged in a) 2-count bottles, NDC 55289-866-02; b) 6-count bottles, NDC 55289-DrugClass II1

PD-Rx Pharmaceuticals, Inc.: all 17 events

Official channels

Cite this page

Recall Register. FDA enforcement event 86533. https://recallregister.com/fda/ii/86533/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA drug enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
Newest FDA report date on the register
23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?
The FDA record gives this distribution: AZ, OK
What quantity of product is in FDA event 86533?
The FDA record gives this quantity: 20 bottles
How did the recall start?
The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2020 have the same class?
64% of the 342 drug events that started in 2020 are in Class II.