FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Pinnacle Food Group, Llc
- Product
- Birds Eye Baby Sweet Peas, Net Wt. 13 oz. (369g ), Keep Froz…
- Reason
- Product has the potential to be contaminated with Listeria monocytogenes.
- Published
- October 18, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Silver Spring Foods, Inc.
- Product
- waterfront Bistro Tatar Sauce, Net Wt 9 oz. (255g), UPC 2113…
- Reason
- Silver Spring is recalling Waterfront Bistro Tartar Sauce because an incorrect back label does not identify egg.
- Published
- October 18, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Choice Antibacterial Hand Soap, (ethyl alcohol 61%) 800 ml/ 27 fl oz, Universal Valve, Inopak LTD, Ringwood, NJ
by Inopak Ltd
- Reason
- GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.
- Published
- October 11, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Mild Healthcare Antibacterial Hand Soap, 6% P.C.M.X., 1000 mL and 2000 mL Disc Pump, 800 mL Universal Valve, and 1 gallon bottles, Inopak. Ltd, Ringwood, NJ 07456
by Inopak Ltd
- Reason
- GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.
- Published
- October 11, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18 fl oz. bottles and 500, mL 800 mL, and 1000 mL pouches, ALSO labeled as STYLE Antibacterial Hand Soap, Inopak Ltd Ringwood, NJ --- NDC 5031-431-02
by Inopak Ltd
- Reason
- GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump
- Published
- October 11, 2017
- Distribution
- Nationwide
View recall →
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 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
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
View recall →
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
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 →
FDA Recall
Terminated
Historical recordClass II
Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL Fill in 5 mL Single dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3375-04
by Pfizer Inc.
- Reason
- Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
- 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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