B-50 capsules, 100-count bottles, labeled in part as Healthy Life Chemistry, By Purity First, Man...

FDA Drug Recall #D-373-2014 — Class I — July 31, 2013

Recall Summary

Recall Number D-373-2014
Classification Class I — Serious risk
Date Initiated July 31, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Healthy Life Chemistry Inc dba Purity First
Location Deer Park, NY
Product Type Drugs
Quantity unknown

Product Description

B-50 capsules, 100-count bottles, labeled in part as Healthy Life Chemistry, By Purity First, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735; 1-800-696-7017

Reason for Recall

Marketed Without An Approved NDA/ANDA: FDA analysis of this product found it to contain undeclared steroids and steroid-like substances making this an unapproved new drug.

Distribution Pattern

Approximately 30% of all finished products were sold to customers in interstate to include but may not be limited to NY, NJ & CT via UPS. Products are promoted and sold directly to customers at Healthy Life Chemistry's retail store at 13A Lucon Drive in Deer Park, NY, on the company website (www.purityfirst.com), and are available at the health food store, Total Health, located at 120 Rte 110, Farmingdale, NY (www.totaldiscountvitamins.com).

Lot / Code Information

lot numbers: F03Q, C02R

Other Recalls from Healthy Life Chemistry Inc dba Purity...

Recall # Classification Product Date
D-374-2014 Class I Multi-Mineral capsules, 200-count bottles, labe... Jul 31, 2013

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

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.