FDA/USDA ~ May/June 2018 Alerts & Safety


  • Ruiz Food Products, Inc. Recalls 12-Count Frozen Breakfast Burritos due to Possible Foreign Matter ContaminationRuiz Food Products, Inc., a Denison, Texas establishment, is recalling approximately 50,706 pounds of frozen breakfast burritos that may be contaminated with extraneous material.
  • Apotex Corp. is voluntarily recalling one (1) lot of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays, to the consumer level. The Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays has been found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump. The issue was discovered through a customer complaint.Risk Statement: There is a potential for patients to be exposed to the glass particles and mechanical irritation cannot be ruled out. Local trauma to the nasal mucosa might occur with use of the defective product. To date, Apotex Corp. has not received any  reports of adverse events related to recall.
    Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays is indicated for the treatment of seasonal and perennial allergic rhinitis and for the management of sinus pain and pressure associated with allergic rhinitis in patients 4 to 17 years of age The affected Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays can be identified by the information in the table below: and on the product label:

    NDC Lot
    Number
    Expiration
    Date
    Strength Configuration/Count
    60505-0829-1 NJ4501 07/2020 50 mcg per
    spray
    120 Metered
    Sprays
    Carton containing 1 Bottle of 50
    mcg per spray 120 Metered Sprays

    The affected Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays was distributed nationwide to wholesalers and distributors.

    Apotex Corp. has notified wholesalers/distributor by recall letter to arrange for return of any recalled product.

    Consumers/wholesalers/retailers/hospitals/institutions with an existing inventory of the lot subject to this recall should stop use and distribution of the remaining units and quarantine immediately. Healthcare Professionals in your organization should be informed of this recall. If you have further distributed the recalled product, to the wholesale or retail level, please notify any accounts or additional locations which may have received the recalled product from you. For additional assistance, call GENCO Pharmaceutical Services, a subsidiary of FedEx Supply Chain (GENCO) at 1- 877-475-5863 (7:00am – 5:00pm, CST Monday thru Friday), to arrange for return of the product.

    Customers with questions regarding this recall can contact Apotex Corp.  by phone-number 1-800-706-5575 (8:30am – 5:00pm, EST Monday thru Friday) or email address UScustomerservice@Apotex.com.  Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

    Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Eddy Packing Co., Inc. Recalls Smoked Sausage Product due to Possible Foreign Matter ContaminationEddy Packing Co., Inc., a Yoakum, Texas establishment, is recalling approximately 18,390 pounds of smoked sausage that may be contaminated with extraneous materials, specifically soft plastic.
  • Haggen has pulled El Monterey products with the following expiration dates from its shelves. These products have been specifically recalled:El Monterey Shredded Steak & Cheese Flour Taquitos, 28 oz  – UPC: 71007-40389. Expiration Dates: 05/05/2014, 05/17/2014, 05/20/2014, 05/22/2014,
    06/07/2014, 10/08/2014, 10/11/2014, 10/16/2014, 10/21/2014, 12/12/2014El Monterey Shredded Steak Corn Taquitos, 28 oz – UPC: 71007-40155. Expiration Dates: 08/15/2014, 08/16/2014, 10/18/2014, 11/11/2014, 12/12/2014, 12/13/2014Reason for Recall:
    Ruiz foods is issuing a recall on certain best if used by dates of EL MONTEREY SHREDDED STEAK AND CHEESE FLOUR TAQUITOS 28 OZ. AND EL MONTEREY SHREDDED STEAK CORN TAQUITOS 28 OZ. The product was manufactured using meat that has been recalled by Rancho Feeding Company. There have been no reports of illnesses due to the consumption of this product.

    All product may be returned for a full refund.

    For more information, please call Ruiz Foods at 1-800-772-6474

     

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