FDA Recall
Terminated
Historical recordClass II
Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL Single patient infusion vial, 500 mg/50 mL (10 mg/mL), NDC 0409-4699-33; c) 100 mL Single patient infusion vial, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA
by Hospira Inc.
- Reason
- Presence of Particulate Matter: Visible particulate and particulate embedded in vials were observed during retain inspection.
- Published
- February 20, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany); NDC 0270-1315-67.
by Bracco Diagnostic Inc
- Reason
- Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
- Published
- February 13, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL (NDC 0270-1316-66), 10 x 100 mL (NDC 0270-1316-67), 10 x 125 mL (NDC 0270-1316-68) Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany).
by Bracco Diagnostic Inc
- Reason
- Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
- Published
- February 13, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Rx only, Mfd by: Bayer HealthCare Pharmaceuticals, LLC Seattle, WA 98101 U.S. Lic. No. 1791 NDC 58468-0181-2
by Bayer Healthcare Pharmaceuticals Inc.
- Reason
- Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point.
- Published
- February 13, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Zicam Extreme Congestion Relief (oxymetazoline HCl) nasal gel, 0.05%, 0.50 fl. oz. (15 mL) spray bottle, Developed and distributed by Zicam LLC, Scottsdale, Arizona 85255, a wholly owned subsidiary of Matrixx Initiatives Inc, NDC 62750-005-10, UPC 7 32216 20410 0.
by Matrixx Initiatives Inc
- Reason
- Microbial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia cepacia.
- Published
- February 13, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass I
Carboplatin Injection, 450 mg/45 mL (10 mg/mL), 45 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, NDC 61703-339-50 (Hospira label) and NDC 61703-360-50 (Novaplus label), Hospira, Inc., Lake Forest, IL 60045, Product of Australia.
by Hospira Inc.
- Reason
- Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
- Published
- February 13, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass I
Carboplatin Injection, 600 mg/60 mL (10 mg/mL), 60 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, Hospira, Inc., Lake Forest, IL 60045, Product of Australia, NDC 61703-339-56.
by Hospira Inc.
- Reason
- Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
- Published
- February 13, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Syeda (drospirenone and ethinyl estradiol), 3 mg/0.03 mg, 3 x 28 tablet blistercards, combination oral contraceptive tablet, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ
by Sandoz Incorporated
- Reason
- Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3.
- Published
- February 13, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
ESTEE LAUDER DayWear Sheer Tint Release, Advanced Multi-Protection Anti-Oxidant Moisturizer Broad Spectrum SPF15, All Skin types, 1.7 FL. OZ. LIQ/50 ml (tube inside a unit carton) with UPC No. 2713179904, Code WKEM-01, and 1.5 mL foil sample packets, ESTEE LAUDER, DIST., NEW YORK, N.Y. 10022 NDC 11559-008-01
by Estee Lauder Inc
- Reason
- Failed Stability Specifications: The active sunscreen ingredient, avobenzone 3%, may not be stable over the shelf life, the sunscreen effectiveness may be less than labeled.
- Published
- February 13, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Carisoprodol Tablets, USP, 350 mg, packaged in a) 500-count tablets per bottle (NDC 0143-1176-05) and b) 1000-count tablets per bottle (NDC 0143-1176-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.
by West-Ward Pharmaceutical Corp.
- Reason
- Presence of Foreign Substance: Uncharacteristic blacks spots on tablets.
- Published
- February 13, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PredniSONE Tablets, USP, 10 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1473-01), b) 1000-count tablets per bottle (NDC 0143-1473-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ 07724.
by West-Ward Pharmaceutical Corp.
- Reason
- Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the tablets.
- Published
- February 13, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
SLIM XTREME Herbal Slimming Capsule, supplied in 30-count bottles. Another Product Forumulated and Distributed By: Globe All Wellness, LLC Hollywood, FL 33020 www.diet66.com Inquires Call 877.842.9873
by Globe All Wellness, LLC
- Reason
- Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.
- Published
- February 13, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lansoprazole Delayed-release Capsules, USP, 30 mg, 500-count capsules per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., Made in India, NDC 0378-8030-05.
by Mylan Pharmaceuticals Inc.
- Reason
- Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets.
- Published
- February 13, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
EstroGel (estradiol gel) 0.06%, contained in 50-gr metered pumps, 1.25g/pump depression, for use as physician starter samples; product is labeled in part ***Manufactured for ASCEND Therapeutics Herndon, VA 20170 by DPT Laboratories San Antonio TX 78215***
by Ascend Therapeutics Inc
- Reason
- Defective Container: Pump head detaching from the canister unit upon removal of the overcap.
- Published
- February 13, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Taztia XT(diltiazem HCI extended release capsules, USP, Once-A-Day Dosage, 360 mg, 90 Capsules per bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, Distributed by: Watson Pharma, NDC 62037-700-90.
by Watson Pharmaceuticals
- Reason
- Failed Dissolution Specification: Out of a specification result occurred during the 3-month stability testing. Dissolution result at the 4-hour time point was 41% (specification: 20-40%).
- Published
- February 13, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Femtrace 0.45 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738
by Warner Chilcott Company LLC
- Reason
- Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
- Published
- February 6, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Femtrace 0.9 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738
by Warner Chilcott Company LLC
- Reason
- Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
- Published
- February 6, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
HILLYARD, Alcohol Free Foaming Instant Hand Sanitizer, Benzalkonium Chloride 0.10%, 1.25 L plastic bottle, OTC, HILLYARD IDUSTRIES, St. Joseph, MO. 64502 NDC 76402-403-03
by Hillyard GMP
- Reason
- Microbial Contamination of Non-Sterile Products: The product may be contaminated with bacteria.
- Published
- February 6, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administration, Rx Only, Cytotoxic, NDC: 0085-1519-02, Schering Corporation, Kenilworth, New Jersey, 07033
by Schering-Plough Products, LLC
- Reason
- Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected during stability monitoring.
- Published
- February 6, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16; b) 60-count bottles, NDC 0603-3888-20; c) 90-count bottles, NDC 0603-3888-02; d) 100-count bottles, NDC 0603-3888-21; e) 120-count bottles, NDC 0603-3888-22; f) 150-count bottles, NDC 0603-3888-26; g) 180-count bottles, NDC 0603-3888-04; h) 500-count bottles, NDC 0603-3888-28; and i) 1000-count bottles, NDC 0603-3888-32, Rx only, Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811.
by Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals
- Reason
- Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets.
- Published
- February 6, 2013
- 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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