FDA Recall
Terminated
Historical recordClass II
Rivastigmine Tartrate Capsules, USP 1.5 mg, 60 count bottle, Rx Only, Mfd. By Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-352-60
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specifications
- Published
- August 19, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
SENSODYNE WITH FLUORIDE REPAIR & PROTECT, a) 0.8 oz.(23 g) tubes, (NDC 0135-0548-01); b) 3.4 oz. (96.4 g) tubes, (NDC 0135-0548-02) Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108
by GlaxoSmithkline Consmer Healthcare
- Reason
- Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
- Published
- August 19, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
SENSODYNE EXTRA FRESH REPAIR & PROTECT, 3.4 oz. (96.4 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0547-02
by GlaxoSmithkline Consmer Healthcare
- Reason
- Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
- Published
- August 19, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
SENSODYNE COMPLETE PROTECTION, 3.4 oz. (96.4 g)tubes, Manufactured by Oratech, South Jordan UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0573-02
by GlaxoSmithkline Consmer Healthcare
- Reason
- Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
- Published
- August 19, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
SENSODYNE EXTRA FRESH COMPLETE PROTECTION, 3.4 oz.(96.4 g) tubes, Manufactured by Oratech, South Jordan UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0572-02
by GlaxoSmithkline Consmer Healthcare
- Reason
- Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
- Published
- August 19, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
biotene PBF Toothpaste (Plaque-Biofilm Loosening Formula), a) 4.3 oz. (121.9 g) tubes, (NDC 0135-0559-01), biotene¿ PBF Paste, b) 4.5 oz.(127.6 g) tubes, (NDC 0135-0490-02), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108
by GlaxoSmithkline Consmer Healthcare
- Reason
- Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
- Published
- August 19, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT , 4.3 oz.(121.9 g) tubes, Manufactured by Oratech, South Jordan, UTAH, 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108 NDC 0135-0558-01
by GlaxoSmithkline Consmer Healthcare
- Reason
- Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
- Published
- August 19, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
biotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original, a) 0.70 oz (19.8 g) tubes., (NDC 0135-0557-02) , b) 0.75 oz. (21.3 g) tubes, (NDC 0135-0487-02), c) 4.3 oz. (121.9 g) tubes, (NDC 0135-0557-01), d) 4.5 oz. (127.6 g) tubes, (NDC 0135-0487-01), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108
by GlaxoSmithkline Consmer Healthcare
- Reason
- Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
- Published
- August 19, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
biotene Gentle Mint Gel, 4.5 oz.(127.6 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0488-01
by GlaxoSmithkline Consmer Healthcare
- Reason
- Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
- Published
- August 19, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/Box, Rx Only. Manufactured for: RANBAXY LABORATORIES, INC Jacksonville, FL 32257 USA. NDC: 10631-133-31.
by Ranbaxy Inc.
- Reason
- Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
- Published
- August 12, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Mometasone Furoate Ointment USP, 0.1%, 15 g tubes, Rx Only, Manufactured by Perrigo, Yeruham 80500, Israel, Distributed by Perrigo, Allegan, MI 49010, NDC 45802-0119-37
by Perrigo Israel Pharmaceuticals
- Reason
- Subpotent drug
- Published
- August 12, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Desmopressin Acetate Tablets, 0.1mg, 100 Count Bottles, Rx Only. Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA; Distributed by Actavis Pharma, Inc. Parsippany, NJ 07054 USA. NDC: 0591-2464-01.
by Actavis Laboratories, FL, Inc.
- Reason
- Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.
- Published
- August 12, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipine) Extended Release tablets, 100-count bottle (NDC 59630-501-10, UPC 3 59630 50110 5), Manufactured for: Shionogi, Inc., Florham Park, NJ 07932; and b) Nisoldipine Extended Release tablets, 100-count bottle (NDC 66993-473-02, UPC 3 6693 47302 4), Manufactured for: Prasco Laboratories, Mason, OH 45040; Rx only; Manufactured by: Aenova France SAS, 38291 Saint Quentin-Falavier, France.
by Shionogi Inc.
- Reason
- Failed Dissolution Specifications
- Published
- August 12, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, (CII), 10 mg (Mixed Salts of a Single Entity Amphetamine Product), 100 count bottles, manufactured at Barr Laboratories, Inc. Forest, VA for Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0555-0972-02
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications: out of specification for unknown impurity
- Published
- August 12, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 mcg/100 mcg per actuation*, 4 Grams, 120 Metered Doses per inhaler, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Made in Germany, NDC 0597-0024-02.
by Boehringer Ingelheim Roxane Inc
- Reason
- Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.
- Published
- August 5, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch, 30 pouches per carton, Rx only, Distributed by Purdue Pharma L.P. Stamford, CT 06901-3431, NDC 59011-265-30
by Purdue Pharma L.P.
- Reason
- Failed dissolution specifications
- Published
- July 29, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Captopril Tablets, USP, 100 mg Tablets, Packaged in 100 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0905-01.
by Wockhardt Usa Inc.
- Reason
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Published
- July 29, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Captopril Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0904-01) and B) 1000 Count Bottles (NDC: 64679-0904-02), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
by Wockhardt Usa Inc.
- Reason
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Published
- July 29, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Captopril Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0903-01) and B) 1000 Count Bottles (NDC: 64679-0903-02), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
by Wockhardt Usa Inc.
- Reason
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Published
- July 29, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Zonisamide Capsules, 25 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0945-01.
by Wockhardt Usa Inc.
- Reason
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Published
- July 29, 2015
- 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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