WP Thyroid, Westhroid Pure, 1.75 Grain (113.75 mg) Thyroid USP, packaged in a) 1,000 Tablets, NDC...

FDA Drug Recall #D-1612-2020 — Class II — August 25, 2020

Recall Summary

Recall Number D-1612-2020
Classification Class II — Moderate risk
Date Initiated August 25, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm RLC Labs Inc.
Location Phoenix, AZ
Product Type Drugs
Quantity N/A

Product Description

WP Thyroid, Westhroid Pure, 1.75 Grain (113.75 mg) Thyroid USP, packaged in a) 1,000 Tablets, NDC 64727-6150-2 ; b) 30 Tablets, NDC 64727-6150-4; c) 60 Tablets, NDC 64727-6150-5; d) 90 Tablets, NDC 64727-6150-6; e) 100 Tablets, NDC 64727-6150-1; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034

Reason for Recall

CGMP Deviations: manufactured under the same conditions as those found to be subpotent.

Distribution Pattern

Nationwide in the United States

Lot / Code Information

All lots with expiry between 10/2020-07/2023

Other Recalls from RLC Labs Inc.

Recall # Classification Product Date
D-1609-2020 Class II WP Thyroid, Westhroid Pure, 1 Grain (65 mg) Thy... Aug 25, 2020
D-1601-2020 Class II Nature-Throid, Thyroid USP [liothyronine (T3) 1... Aug 25, 2020
D-1599-2020 Class II Nature-Throid, Thyroid USP [liothyronine (T3) 1... Aug 25, 2020
D-1597-2020 Class II Nature-Throid, Thyroid USP [liothyronine (T3) 6... Aug 25, 2020
D-1598-2020 Class II Nature-Throid, Thyroid USP [liothyronine (T3) 4... Aug 25, 2020

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.