The Recall Desk
CriticalFDA (Drugs)·D-373-2014·Announced 2013-12-25

Purity First B-50 Capsules Recalled for Undeclared Steroids

Healthy Life Chemistry is recalling B-50 capsules because FDA analysis found undeclared steroids, making the product an unapproved new drug.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Healthy Life Chemistry Inc dba Purity First is recalling B-50 capsules, 100-count bottles, because FDA analysis found the product contains undeclared steroids and steroid-like substances. This finding makes the product an unapproved new drug that was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

The recalled product is labeled in part as Healthy Life Chemistry, By Purity First, and manufactured for Purity First Health Products, Inc. The specific lot numbers involved are F03Q and C02R. The company is located at 51 Florida Street, Farmingdale, NY 11735, and can be reached at 1-800-696-7017.

Approximately 30% of the finished products were sold to customers in interstate commerce, including New York, New Jersey, and Connecticut, via UPS. The products are also 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 at the health food store Total Health, located at 120 Rte 110, Farmingdale, NY (www.totaldiscountvitamins.com). Consumers should stop using the product and contact the manufacturer for instructions.

The recalled product

Product
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

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • lot numbers: F03Q
  • C02R

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 2 recalled by Healthy Life Chemistry Inc dba Purity First under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Healthy Life Chemistry Inc dba Purity First

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