FDA Recall
Terminated
Historical recordClass II
CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride Rb 82, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Medi-Physics, Inc. South Plainfield, NJ 07080, NDC 0270-0091-01
by Bracco Diagnostics Inc
- Reason
- GMP deviation; Sr-82 levels exceeded alert limit specification
- Published
- October 3, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30
by Apace KY LLC
- Reason
- Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.
- Published
- September 26, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Paclitaxel Injection, 6 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; N DC 61703-342-50
by Hospira Inc.
- Reason
- The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
- Published
- September 26, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Methotrexate Injection, USP, 25 mg/mL, 40 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; NDC 61703-408-41
by Hospira Inc.
- Reason
- The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
- Published
- September 26, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cytarabine Injection, 20 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; NDC 61703-303-46
by Hospira Inc.
- Reason
- The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
- Published
- September 26, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Carboplatin Injection, 10 mg/mL, 45 mL Multi-Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia, NDC 61703-339-50 (Hospira label), NDC 61703-360-50 (Novoplus label)
by Hospira Inc.
- Reason
- The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are beig recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
- Published
- September 26, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5248-92
by Sandoz Incorporated
- Reason
- Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
- Published
- September 26, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781- 5249-92,
by Sandoz Incorporated
- Reason
- Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
- Published
- September 26, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dukal Corporation BZK Swab, First Aid Antiseptic, (Benzalkonium Chloride), 0.133% w/v, Item 854-1000 contains 1000 individually packaged swabs per box. Item 854 contains 200 individually packaged swabs per box. Packaging labeled with Dukal Corporation, Hauppauge, NY 11788 --- NDC 65517-00031
by Dukal Corp.
- Reason
- Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer)
- Published
- September 26, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ZEE Antiseptic Wipes, First Aid Antiseptic, Benzalkonium chloride 0.133% (effective concentration), over the counter; supplied in 10 (item 2633), 50 (items 0204 and 02040 [sold in Canada only]) and 100 (item 0271) wipes per box distributed by ZEE MEDICAL, INC., Irvine, CA
by Dukal Corp.
- Reason
- Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer)
- Published
- September 26, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 260415, Carefusion, Leawood, KS 66211, USA
by CareFusion 213, LLC
- Reason
- Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging.
- Published
- September 26, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Little Remedies For Tummys, Stimulant Laxative (sennosides) Drops, 1 FL OZ (30 mL), Dist. by Medtech Products Inc., Irvington, NY 10533, UPC 7 56184 12071 2.
by Medtech Products, Inc.
- Reason
- Subpotent (Single Ingredient) Drug: This product is being recalled because of sub-potency of the sennosides.
- Published
- September 12, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-4699-24
by Hospira Inc.
- Reason
- Presence of Particulate Matter: A single visible particulate was observed and confirmed in a sample bottle during retain inspection.
- Published
- September 5, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Oasis Age Essential (cetylpyridinium chloride) Mouthwash, 0.06%, 473 mL (16 fl oz) bottle, Oasis Consumer Healthcare LLC, 812 Huron Road, Cleveland, Ohio 44115, UPC 8 51076 00300 2.
by Natural Essentials Inc
- Reason
- Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepacia.
- Published
- September 5, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, This cup delivers 10 mL, Rx Only, Manufactured by VistaPharm, Inc., Largo FL33771
by VistaPharm, Inc.
- Reason
- Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," instead of "10 mL x 50,"
- Published
- September 5, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Packaged by American Health Packaging, 2550-A John Glenn Avenue, Columbus, OH 43217, barcode 6808432511; Carton labeling Dist by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977, NDC 68084-325-21.
by American Health Packaging
- Reason
- Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.
- Published
- September 5, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, NDC 60505-0833-5.
by Apotex Corp.
- Reason
- CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
- Published
- September 5, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered Inhalations, FOR ORAL INHALATION ONLY - For use with Ventolin HFA actuator only. Net. wt. 18 g Rx only, GlaxoSmithKline, Reasearch Triangle Park, NC 27709 NDC 0173-0682-20
by GlaxoSmithKline Inc
- Reason
- Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.
- Published
- September 5, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package - Not for Direct Infusion, For Intravenous Use, Rx only, a) 50 mL Single Dose Vial, b) 100 mL Single Dose Vial, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Nycomed GmbH, 78224 Singen (Germany), NDC a) 0270-5264-16, b) 0270-5264-17.
by Bracco Diagnostics Inc
- Reason
- Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
- Published
- September 5, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Eco-Dent Sparkling Clean Mint Ultimate Essential MouthCare, Natural Daily Rinse and Oral Wound Cleanser/Oral Debriding Agent, 8 fl oz (237 mL) bottle, Alcohol Free, Dist By: Eco Dent, 1100 Lakes Dr., Silver Lake, WI 53170 USA, UPC Code: 00037541
by Capco Custom Packaging Inc
- Reason
- Microbial Contamination of Non-Sterile Products; Product was found to be contaminated with Sphingomonas paucimobilis bacteria.
- Published
- September 5, 2012
- 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.
Read the full medical disclaimer.