FDA Recall
Terminated
Historical recordClass III
Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL vial. Intravenous, Intramuscular, Subcutaneous Use, Rx Only, Hospira, Inc., Lake Forest IL USA, NDC 0406-2336-10.
by Pfizer Inc.
- Reason
- CGMP Deviations: Firm failed to control impurity for color change at the API stage.
- Published
- October 11, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Coborn's, Inc
- Product
- Coborn's/Cash Wise Caraway Rye Bread - UPC 7-33147-20155-8…
- Reason
- While reviewing the allergen listings for our products and cross referencing against the updated spec sheet from the manufacturer of the bread base, it was discovered that the allergen statement had been updated from only wheat to wheat, milk, egg and soy.
- Published
- October 11, 2017
- Distribution
- Coborn's, Marketplace, and Cashwise stor…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Coborn's, Inc
- Product
- Coborn's/Cash Wise American Rye Bread - UPC 7-33147-20150 N…
- Reason
- Coborn's Inc is recalling packages of its American Rye Bread and Caraway Bread, which contain undeclared allergens (milk, soy, and egg) as a result of an update to the ingredient profile from the manufacturer of the base.
- Published
- October 11, 2017
- Distribution
- Coborn's, Marketplace, and Cashwise stor…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Garden Of Life, LLC
- Product
- Garden of Life, Baby Organic Liquid probiotic formula, 56 ml…
- Reason
- The product may pose a choking hazard to newborns due to the thickness of the liquid.
- Published
- October 11, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
J R Simplot Co Corporate HQ
- Product
- Simplot Traditional Tater Gem. Net Wt. 30 lb. (13.6 kg),…
- Reason
- Simplot Traditional Tater Gem, foodservice case (6/5 lbs. bags), is recalled because customer reported that small pieces of rigid plastic were embedded in some tater gems.
- Published
- October 11, 2017
- Distribution
- distributed in AR, AZ, CA, CO, HI, IA, I…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Pro Bioteks Laboratories
- Product
- Bio35, Vitamin-Mineral Omega Oils Trace Minerals Dietary Sup…
- Reason
- Bio-35 has undeclared soy lecithin.
- Published
- October 11, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
KIND LLC
- Product
- KIND Dark Chocolate Nuts and Sea Salt Bar-containing 12 /1.…
- Reason
- Outer box fails to declare the allergen walnuts, the individual bar is properly labeled
- Published
- October 11, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78) packaged in 10-count shrink wrap packs (NDC 0781-3407-95), Rx only, Manufactured in Austria by Sandoz GmbH or Sandoz Inc., Princeton, NJ 08540.
by Sandoz Inc
- Reason
- Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.
- Published
- October 4, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Acarbose Tablets, 25 mg, 100-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; NDC 16252-523-01.
by Teva Pharmaceuticals USA
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: An incorrect expiration date of July 2018 is printed on the product labeling rather than the correct expiration date of July 2017.
- Published
- October 4, 2017
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 USA for Genentech, Inc., South San Francisco, CA 94080-4990. NDC 50242-901-24
by Pfizer Inc.
- Reason
- Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.
- Published
- October 4, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
House Of Thaller Inc
- Product
- Marketside CLASSIC HUMMUS WITH PINE NUTS NET WT. 10 oz (283g…
- Reason
- The firm was notified by their ingredient supplier that the pine nuts may be contaminated with Listeria monocytogenes.
- Published
- October 4, 2017
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
House Of Thaller Inc
- Product
- LANTANA White Bean HUMMUS NET WT. 10 oz (283g)
- Reason
- The firm was notified by their ingredient supplier that the pine nuts may be contaminated with Listeria monocytogenes.
- Published
- October 4, 2017
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
House Of Thaller Inc
- Product
- FRESH FOODS MARKET Artisan Humus Pine Nuts NET WT 10 oz (283…
- Reason
- The firm was notified by their ingredient supplier that the pine nuts may be contaminated with Listeria monocytogenes.
- Published
- October 4, 2017
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
Terminated
Historical recordClass I
Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml vial of sterile water for Injection USP and one transfer device. Manufactured by: Genentech, Inc. 1 DNA Way, South San Francisco, CA 84080-4990. NDC: 50242-0085-27
by Genentech, Inc.
- Reason
- Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
- Published
- September 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Aminocaproic Acid, USP (6-Aminohexanoic Acid) active pharmaceutical ingredient, packaged in a) 100 g jar (NDC 38779-0989-05, b) 1 kg jar (NDC 38779-0989-09), and 25 kg drum (NDC 38779-0989-07), Rx only, Packed by Medisca Inc., Plattsburgh, NY 12901, CAS: 60-32-1. 38779-0989-05; jar, 300 ml, white HDPE 38779-0989-07; drum, 15 gallon, Fiber 38779-0989-09; 2.8L, white, HDPE
by Medisca, Inc.
- Reason
- CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pharmacy Compounding Use.
- Published
- September 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1 mL vials (NDC 59676-310-01), b) box of 25 single use 1 mL vials (NDC 59676-310-02), Rx Only, Manufactured by: Amgen, Inc. Thousand Oaks, CA 91320, Manufactured for: Janssen Products, LP Horsham, PA 19044
by Amgen, Inc.
- Reason
- Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
- Published
- September 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Daytrana (methylphenidate transdermal system) Delivers 15 mg over 9 hours (1.6 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5553-3
by Noven Pharmaceuticals, Inc.
- Reason
- Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
- Published
- September 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5555-3
by Noven Pharmaceuticals, Inc.
- Reason
- Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
- Published
- September 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5554-3
by Noven Pharmaceuticals, Inc.
- Reason
- Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
- Published
- September 27, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5552-3
by Noven Pharmaceuticals, Inc.
- Reason
- Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
- Published
- September 27, 2017
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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