Lloyd Thyro-Tab 0.200 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for ...

FDA Drug Recall #D-444-2013 — Class II — April 1, 2013

Recall Summary

Recall Number D-444-2013
Classification Class II — Moderate risk
Date Initiated April 1, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Lloyd Inc. of Iowa
Location Shenandoah, IA
Product Type Drugs
Quantity 5,771,989 tablets

Product Description

Lloyd Thyro-Tab 0.200 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.

Reason for Recall

cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.

Distribution Pattern

The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.

Lot / Code Information

Lot #: HD29411, Exp May-13; HE00512, Exp Jul-13; HF062122, Exp Sep-13.

Other Recalls from Lloyd Inc. of Iowa

Recall # Classification Product Date
D-433-2013 Class II Lloyd Thyro-Tab 0.050 mg., packaged in 150,000-... Apr 1, 2013
D-442-2013 Class II Lloyd Thyro-Tab 0.150 mg., packaged in 150,000-... Apr 1, 2013
D-448-2013 Class II Levothroid (levothyroxine sodium tablets, USP),... Apr 1, 2013
D-446-2013 Class II Levothroid (levothyroxine sodium tablets, USP),... Apr 1, 2013
D-449-2013 Class II Levothroid (levothyroxine sodium tablets, USP),... Apr 1, 2013

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.