Digestive, Enzyme Supplement, packaged 90 capsules per bottle, 135 capsules p...
FDA Recall #F-1453-2014 — Class II — October 25, 2013
Recall Summary
| Recall Number | F-1453-2014 |
| Date Initiated | October 25, 2013 |
| Classification | Class II |
| Status | Terminated |
| Type | Voluntary: Firm initiated |
| Product Type | Food |
Recalling Firm
| Firm | Health Wright Products Inc |
| Location | Clackamas, OR |
Product Description
Digestive, Enzyme Supplement, packaged 90 capsules per bottle, 135 capsules per bottle, or 270 capsules per bottle. They are sold under brand Enzyme Research Products or Empower Life.
Reason for Recall
Dietary supplement products are recalled because they were made from ingredient that was contaminated with Chloramphenicol.
Classification
Class II — A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution Pattern
Distributed to California, Florida, Oregon, Utah, and Mexico
Product Quantity
1199 bottles of 90 ct; 2081 bottles of 135 ct; 9799 bottles of 270 ct;
Product Codes / Lot Numbers
Digestive (90 count): LOT #1206801, EXP 03/15 (means March 2015); Digestive (135 count): LOT # 1108103, EXP 03/14 (means March 2014); LOT# 1234006, EXP 12/15 (means December 2015) for Empower Life Nutrition brand. Digestive (270 count): LOT# 1127002, EXP 09/14 (means September 2014); LOT# 1120606, EXP 07/14 (means July 2014); LOT# 1113201, EXP 05/14 (means May 2014); LOT# 1029104, EXP 10/13 (means October 2013); LOT# 1215601, EXP 06/15 (means June 2015); LOT# 1234006, EXP 12/15 (means December 2015).
What Should You Do?
Stop consuming this product immediately. Check your home for the recalled item and dispose of it safely. If you experienced a health issue after consuming this product, contact your doctor and report it to the FDA MedWatch.
Frequently Asked Questions
Stop consuming the product immediately and do not donate or give it to others. Check the recall notice above for specific disposal or return instructions. Many food recalls ask you to throw the product away and retain the packaging for a possible refund from the retailer. If you purchased it online, check your order history — some retailers send recall notifications directly to customers. You do not need a receipt to report an issue or seek a refund; the fact of purchase is typically sufficient.
In most cases, yes. Retailers are typically notified to accept returns of recalled products and issue refunds, regardless of whether you have a receipt. Check with the store where you purchased the item. Some manufacturers also offer direct refunds — contact the recalling firm using the information in the official recall notice. If you purchased the product online, contact the retailer's customer service with your order number. In either case, you generally do not need original packaging, though retaining the product label with the lot code or UPC can speed up the process.
Report foodborne illnesses and adverse food reactions to the FDA through the MedWatch Safety Reporting Portal at FDA.gov, or by calling 1-800-332-1088. You can also report issues directly to the FDA's Safety Reporting Portal at SafetyReporting.hhs.gov. If you believe there is an immediate public health risk, contact your local health department. Your report helps the FDA identify contamination patterns, initiate recalls faster, and protect other consumers from the same hazard. Include as much detail as possible: the product name, lot code, purchase date and location, and a description of your symptoms or findings.
The FDA assigns a status to each recall action throughout its lifecycle. "Ongoing" means the recall is active — the firm is still working to remove the product from commerce and notify consumers. "Completed" means the recall strategy has been implemented and the FDA has determined that the recalling firm has taken all appropriate steps to remove the product. "Terminated" means the FDA has reviewed the results and concluded the recall is complete. Even if a recall is marked as completed or terminated, you should still discard any recalled products you find at home — the recall status refers to the firm's compliance actions, not the safety of product still in consumers' possession.