FDA Recall
Terminated
Historical recordClass II
EXPAREL (bupivacaine liposome injectable suspension), 1.3%, 266 mg/20 mL (13.3 mg/mL) single use vials, INVESTIGATIONAL USE. For Infiltration Only. Not for any other route of administration. Manufactured by Paelra Pharmaceuticals. Inc., San Diego, California, USA
by Pacira Pharmaceuticals, Inc.
- Reason
- Subpotent; bupivacaine
- Published
- March 6, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Crest PRO-HEALTH CPC Antigingivitis/Antiplaque Oral Rinse, 250 mL (8.4 fl oz),Dist. by Procter & Gamble, Cincinnati, OH 45202 NDC 37000-452-02
by Procter & Gamble Hair Care Llc
- Reason
- Cross Contamination with Other Products: Product was mixed with another type of mouth wash.
- Published
- February 27, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg; 100 Tablets (5 x 20), 5 cards each containing 20 blistered tablets per carton, Rx only; Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, Pkg by & Distributed by UDL Laboratories, Inc., Rockford, IL 61103; NDC 51079-254-21.
by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Reason
- Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
- Published
- February 27, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Lac-Hydrin (ammonium lactate) Cream, 12%, packaged in a) 280 g (2 x 140 g tubes), NDC 10631-099-28; b) 385 g bottle, NDC 10631-099-38; Rx only, Ranbaxy, Jacksonville, FL 32257 USA.
by Ranbaxy Inc.
- Reason
- Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
- Published
- February 20, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Lac-Hydrin (ammonium lactate) Lotion, 12%, packaged in 400 g bottles, Rx only, Ranbaxy, Jacksonville, FL 32257 USA, NDC 10631-098-14.
by Ranbaxy Inc.
- Reason
- Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
- Published
- February 20, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
12-Hour Sinus (oxymetazoline hydrochloride) Nasal Spray, 0.05%, 1 FL OZ (30 mL), labeled as a) 12 HOUR SINUS Nasal Spray, Best Choice, Proudly Distributed By: Valu Merchandisers, Co., Kansas City, MO 64111, UPC 0 70038 61226 1; b) Nasal Spray Sinus, Distributed by Discount Drug Mart, Medina, Ohio 44258, UPC 0 9335112623 9; c) sinus relief nasal spray, Distributed By DUANE reade, 440 Ninth Avenue, NY, NY 10001, UPC 6 39194 04551 3; d) 12 Hour Nasal Relief Sinus Nasal Spray, Distributed by: Lee Pharmaceuticals, South El Monte, CA 91733, UPC 0 23558 69230 5; e) Sinus Nasal Spray, Premier Value, Distributed By: Chain Drug Consortium, LLC, 2300 NW Corporate Blvd., Suite 115, Boca Raton, FL 33431, UPC 8 40986 01517 5, NDC 68016-0307-03; f) Nasal Relief Sinus Squeeze Spray, Distributed By Quality Choice, Novi, Michigan 48376-0995, UPC 6 35515 99012 8, NDC 63868-0062-30; g) sinus relief nasal spray, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, UPC 0 11822 14576 3; h) Sinus Nasal Spray, Distributed by: Select Brand Distributors, Pine Bluff, AR 71603, UPC 015127 02305 4, NDC 15127-889-30.
by Lee Pharmaceuticals, Inc
- Reason
- Microbial Contamination of a Non-Sterile Products: 12-Hour Sinus Nasal Spray under various labeling are being recalled due to microbial contamination identified during testing.
- Published
- February 20, 2013
- Distribution
- Nationwide
View recall →
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 →
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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