FDA Recall
Terminated
Historical recordClass I
Gemcitabine for Injection, USP, 1 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-462-01, UPC 3 67457 46201 1.
by Mylan Institutional LLC
- Reason
- Presence of Particulate Matter
- Published
- August 26, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Gemcitabine for Injection, USP, 2 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-463-02, UPC 3 67457 46302 5.
by Mylan Institutional LLC
- Reason
- Presence of Particulate Matter
- Published
- August 26, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-Use Vial, Rx only, labeled as a) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-464-20, UPC 3 67457 46420 6; and b) Distributed by Pfizer Labs, Division of Pfizer Inc, New York, NY 10017, Made in India, NDC 0069-3857-10, UPC 3 00693 85710 4.
by Mylan Institutional LLC
- Reason
- Presence of Particulate Matter
- Published
- August 26, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
CARBOplatin Injection 450 mg/45 mL (10 mg/mL), 45 mL packaged in a 100 mL Multi-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-493-46, UPC 3 67457 49346 6.
by Mylan Institutional LLC
- Reason
- Presence of Particulate Matter
- Published
- August 26, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
PYROLA Advanced Joint Formula capsules, 60-count bottle, G & C Natural Nutrition Inc., Fullerton, CA 92833, UPC 7 11746 00075 8.
by GC Natural Nutrition, Inc.
- Reason
- Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared diclofenac, a prescription non-steroidal anti-inflammatory drug, and chlorpheniramine, an over-the-counter antihistimine, making this an unapproved drug.
- Published
- August 26, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-0152-01), packaged in 10 x 5 mL Vials per carton (NDC 0069-0152-02), Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017.
by Mylan Institutional LLC
- Reason
- Presence of Particulate Matter
- Published
- August 19, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, packaged in 5 x 2 mL vials per carton, Rx only, labeled as a) Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-0146-01; and b) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-467-99.
by Mylan Institutional LLC
- Reason
- Presence of Particulate Matter
- Published
- August 19, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius Kabi USA 2020 N Ruby Street, Melrose Park, IL 60160-1112 for Fresenius Kabi USA, 3 Corporate Dr Lake Zurich, IL 60047-8930. NDC 63323-614-01
by Fresenius Kabi USA, LLC
- Reason
- Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)
- Published
- August 19, 2015
- Distribution
- Nationwide
View recall →
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 →
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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