Nature-Throid 1 GR (65 mg), Each Tablet Contains: Thyroid USP 1 GR (65 mg), Liothyronine (T3) 9 m...

FDA Drug Recall #D-0005-2021 — Class II — September 17, 2020

Recall Summary

Recall Number D-0005-2021
Classification Class II — Moderate risk
Date Initiated September 17, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm PD-Rx Pharmaceuticals, Inc.
Location Oklahoma City, OK
Product Type Drugs
Quantity 20 bottles

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.

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.

Distribution Pattern

AZ, OK

Lot / Code Information

Lot #: J18C68 Exp. 10/31/20

Other Recalls from PD-Rx Pharmaceuticals, Inc.

Recall # Classification Product Date
D-0163-2025 Class II DULoxetine DR USP, 30 mg, 90-count bottle, Rx O... Dec 4, 2024
D-0558-2023 Class II Simvastatin USP, 10 mg, Rx only, Intas Pharm, L... Apr 6, 2023
D-0559-2023 Class II Glimepiride USP, 4 mg, 90 count-bottles, Rx onl... Apr 6, 2023
D-0560-2023 Class II Simvastatin USP 20 mg, Rx only, Intas Pharm. Li... Apr 6, 2023
D-0557-2023 Class II Montelukast Sodium USP, 10 mg, 30 count-bottles... Apr 6, 2023

Frequently Asked Questions

cGMP stands for Current Good Manufacturing Practice — the FDA's regulations governing drug manufacturing quality. A cGMP recall means the company failed to follow required manufacturing standards. This could involve inadequate testing, poor environmental controls, documentation failures, or process deviations. cGMP recalls do not always mean the product is directly harmful — in many cases, quality records are insufficient to confirm the product meets specifications. However, the FDA requires a recall because without proper documentation, product quality cannot be assured. These are often Class II or Class III recalls.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.