FDA Recall
Terminated
Historical recordClass III
Montelukast Sodium Tablets, 10 mg (base), packaged in a) 30-count tablets per bottle (NDC 68462-392-30) and b) 90-count tablets per bottle (NDC 68462-392-90), Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah, NJ 07430.
by Glenmark Generics Inc., USA
- Reason
- Chemical Contamination: The recall has been initiated based on multiple complaints received from pharmacists and consumers reporting that they detected an off-odor, described as moldy, musty or fishy in nature which has been identified as trace levels of Tribromoanisole (TBA) and Trichloroanisole (TCA).
- Published
- March 13, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Citalopram tablets USP, 40mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-344-30
by Dr. Reddy's Laboratories, Inc.
- Reason
- Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.
- Published
- March 6, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Citalopram tablets USP, 20mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-343-30
by Dr. Reddy's Laboratories, Inc.
- Reason
- Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.
- Published
- March 6, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Citalopram tablets USP, 10mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-342-30
by Dr. Reddy's Laboratories, Inc.
- Reason
- Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.
- Published
- March 6, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifenesin 400 mg/Expectorant, a) 24 coated caplets per blister pack, UPC 300240537879, b) 60 coated caplets per blister pack, UPC 300240537855, Bayer HealthCare LLC, Consumer Care, P.O. Box 1910, Morristown, NJ, 07962.
by Bayer Healthcare, LLC
- Reason
- Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton label.
- Published
- March 6, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: There is a potential for the solution to leak from the administration port of the primary container.
- Published
- March 6, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles, Rx Only, NDC 67767-142-30 Actavis Distributed by: Actavis South Atlantic LLC Sunrise, FL 33325 Packaged by by: America Health Packaging Columbus, OH 43217
by Actavis Pharmaceuticals
- Reason
- Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.
- Published
- March 6, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-329-09
by Amedra Pharmaceuticals LLC
- Reason
- Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
- Published
- March 6, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-328-09
by Amedra Pharmaceuticals LLC
- Reason
- Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
- Published
- March 6, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-327-09
by Amedra Pharmaceuticals LLC
- Reason
- Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
- Published
- March 6, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, USP 0.0194 mg; scopolamine HBr, USP 0.0065 mg) with Phenobarbital (USP 16.2 mg) Tablets, packaged in a) 1000-count tablets per bottle (NDC 0143-1140-10; b) 5000-count tablets per bottle (NDC 143-1140-51); Rx only, Manufactured by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724
by West-Ward Pharmaceutical Corp.
- Reason
- Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.
- Published
- March 6, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Furosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop Vial, Rx only, Hospira Inc., Lake Forest, IL --- NDC 0409-6102-04
by Hospira, Inc.
- Reason
- Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial
- Published
- March 6, 2013
- Distribution
- Nationwide
View recall →
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 →
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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