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Ferrous Sulfate Tablets 325 mg, 100 count bottles, Nutritional Supplement. ...

FDA Recall #F-1304-2013 — Class III — March 18, 2013

Recall Summary

Recall NumberF-1304-2013
Date InitiatedMarch 18, 2013
ClassificationClass III
StatusTerminated
TypeVoluntary: Firm initiated
Product TypeFood

Recalling Firm

FirmMagno Humphries Inc
LocationTigard, OR

Product Description

Ferrous Sulfate Tablets 325 mg, 100 count bottles, Nutritional Supplement. Label reads in part "OPTIMUM *** FERROUS SULFATE 325 * mg 5 Grain *** Gluten Free Dietary Supplement *** Manufactured & Distributed by: Magno-Humphries Labs Tigard, OR 97223 U.S.A. *** *325 mg calculated as Ferrous Sulfate Heptahydrate. ***" UPC 0 43292 56306 0 There are 72 bottles per shipping case and most product is shipped by case.

Reason for Recall

The firm found minute pieces of blue material identified by their raw material supplier as polypropylene, a relatively inert plastic.

Classification

Class III — A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

Distribution Pattern

Distributed to only one consignee with several locations nationwide.

Product Quantity

40369 bottles

Product Codes / Lot Numbers

Product code -L6430-100-01(L is designate label, 6430 is the firm's internal product code, 100 is for 100 count and 01 stands for Optimum label, and 0 is the firm's version number. All of these products have the same label code, however; they have different lot numbers. Lot Numbers: 343617, 343718, 343739, 343753, 343814, 343888, and 343959. Expiration dates 11/15, 12/15, 12/15, 12/15, 12/15, 1/16 and 1/16 respectively (expiration dates are month and year) The lot number and expiration date is stamped on the bottom of the bottles.

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.

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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.

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