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Class II: temporary or reversible health riskTerminated

PD-Rx Pharmaceuticals Nature-Throid 1 GR Recall

Nature-Throid 1 GR (65 mg), Each Tablet Contains: Thyroid USP 1 GR (65 mg), Liothyronin…

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

Risk level
Class II
Reported by FDA
Oct 14, 2020
Recall ID
D-0005-2021
Check your lot numberHow we source this data

Summary

PD-Rx Pharmaceuticals recalled Nature-Throid 1 GR starting Sep 17, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0005-2021 on Oct 14, 2020. Reason: CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured under the same conditions as products found to be sub-potent. Status: Terminated.

Why it was recalled

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

Product description

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.

Lot numbers, UPCs & expiration codes

Lot #: J18C68 Exp. 10/31/20

Where it was sold

AZ, OK

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0005-2021
Classification
Class II
Status
Terminated
Recall initiated
Sep 17, 2020
FDA report date
Oct 14, 2020
Quantity
20 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
PD-Rx Pharmaceuticals, Inc.

Original FDA data

Every field from FDA enforcement report D-0005-2021, exactly as published.

Show all FDA fields
City
Oklahoma City
State
OK
Status
Terminated
Country
United States
Event ID
86533
Address
727 N Ann Arbor Ave
Code information
Lot #: J18C68 Exp. 10/31/20
Postal code
73127-5822
Report date
Oct 14, 2020
Product type
Drugs
Recall number
D-0005-2021
Classification
Class II
Recalling firm
PD-Rx Pharmaceuticals, Inc.
Product quantity
20 bottles
Termination date
Nov 5, 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.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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.
Distribution pattern
AZ, OK
Recall initiation date
Sep 17, 2020
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date
Oct 2, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0005-2021, published Oct 14, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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