FDA Recall
Terminated
Historical recordClass II
Wal-Mucil 100% Natural Fiber, 100% Natural Psyllium Seed Husk, Fiber Laxative/Supplement, a)160 capsules per bottle (item #503663), and b) 320 capsules per bottle (Item #586143), Distributed by: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015-4616, www.walgreens.com, a) UPC 3-11917-08151-9, b) UPC 3-11917-07658-4
by Raritan Pharmaceuticals, Inc.
- Reason
- Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
- Published
- October 31, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Up&Up Psyllium Fiber Supplement, 100% natural psyllium husk, Fiber Therapy for Regularity/Fiber Supplement, 160 capsules per bottle, Distributed by: Target Corp., Minneapolis, MN 55403, Made in USA, NDC 11673-059-87, UPC 3-68163-11926-8.
by Raritan Pharmaceuticals, Inc.
- Reason
- Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
- Published
- October 31, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Leader Fiber Capsules, 100% Natural Psyllium Fiber Laxative, Dietary Fiber Supplement, Relieves Constipation, Restores Regularity, 100 capsules per bottle, Distributed by: Cardinal Health, Dublin, OH 43017 www.myleader.com, NDC 37205-372-78, UPC 0-96295-11222-1.
by Raritan Pharmaceuticals, Inc.
- Reason
- Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
- Published
- October 31, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Equate Fiber Therapy, 100% Natural Psyllium Husk Fiber, Fiber Laxative/Fiber Supplement, 160 capsules per bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 68163-119-60, UPC 6-81131-77922-7.
by Raritan Pharmaceuticals, Inc.
- Reason
- Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
- Published
- October 31, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CVS Pharmacy Fiber Capsules for Regularity, Dietary Fiber Supplement, 100 Capsules per bottle, Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895 www.cvs.com UPC 0-50428-07739-9
by Raritan Pharmaceuticals, Inc.
- Reason
- Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
- Published
- October 31, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Best Choice Health Care, Psyllium Fiber Supplement, 100% natural Psyllium Fiber Laxative, 100 capsules per bottle, Proudly Distributed by: Valu Merchandisers, Co., Kansas City, KS 06106, UPC 0-70038-63439-3
by Raritan Pharmaceuticals, Inc.
- Reason
- Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
- Published
- October 31, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
HYDROmorphone HCl Injection, USP, 2 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-count Carpujects per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1312-30, Barcode (01) 1 030409 131230 9 (carton), (01) 0 030409 131230 2 (cartridge unit).
by Hospira Inc.
- Reason
- Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfilled and contain more than the 1 mL labeled fill volume.
- Published
- October 31, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sample-Not For Sale, 7 Tablets per Carton, 5 mg/500 mg, Rx only, Manufactured By: Bristol-Myers Squibb Company, Princeton NJ 08543, USA, Marketed By: Bristol-Myers Squibb Company, Princeton NJ 08543, USA and AstraZeneca Pharmaceuticals LP, Wilmington DE 19850.
by Bristol-Myers Squibb Company
- Reason
- Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as Kombiglyze XR 2.5mg/1000mg on the external package carton, whereas the contents were Kombiglyze XR 5 mg/500 mg blister packaged tablets. The individual blister units are labeled correctly.
- Published
- October 31, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sample-Not For Sale, 6 Tablets per Carton, 2.5 mg/1000 mg, Rx only, Manufactured By: Bristol-Myers Squibb Company, Princeton NJ 08543, USA, Marketed By: Bristol-Myers Squibb Company, Princeton NJ 08543, USA and AstraZeneca Pharmaceuticals LP, Wilmington DE 19850.
by Bristol-Myers Squibb Company
- Reason
- Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as Kombiglyze XR 2.5mg/1000mg on the external package carton, whereas the contents were Kombiglyze XR 5 mg/500 mg blister packaged tablets. The individual blister units are labeled correctly.
- Published
- October 31, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Necon 1/35-28 (norethindrone and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Pharma, Inc., A subsidiary of Watson Pharmaceuticals, Inc., Corona, CA 92880 USA; NDC 52544-552-28.
by Watson Laboratories Inc
- Reason
- Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).
- Published
- October 31, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Necon 10/11 (norethindrone and ethinyl estradiol) Tablets USP, 0.5 mg/35 mcg, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA; Distributed by: Watson Pharma, Inc.; NDC 52544-554-28.
by Watson Laboratories Inc
- Reason
- Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).
- Published
- October 31, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Zenchent (norethindrone and ethinyl estradiol) Tablets USP, 0.4 mg/0.035 mg, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA; Distributed by: Watson Pharma, Inc., Corona, CA 92880 USA; NDC 52544-953-28.
by Watson Laboratories Inc
- Reason
- Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).
- Published
- October 31, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lutera (levonorgestrel and ethinyl estradiol) Tablets USP, 0.1 mg/0.02 mg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA; Distributed by: Watson Pharma, Inc., Parsippany, NJ 07054 USA; NDC 52544-949-28.
by Watson Laboratories Inc
- Reason
- Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).
- Published
- October 31, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Zovia (ethynodiol diacetate and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA; Distributed by: Watson Pharma, Inc.; NDC 52544-383-28.
by Watson Laboratories Inc
- Reason
- Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).
- Published
- October 31, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
BiCNU (Carmustine for injection) 100 mg and Diluent Rx Only BiCNU manufactured by: Ben Venue Laboratories, Inc. Bedford, OH 44146 Diluent manufactured by: Luitpold Pharmaceuticals, Inc. Shirley, NY 11967 Distributed by: Bristol-Meyers Squibb Company Princeton, NJ 08543 USA Made in USA NDC 0015-3012-18 NDC 0015-3012-60
by Bristol-Myers Squibb Company
- Reason
- Superpotent (Single Ingredient) Drug: All BiCNU lots within expiration which contain carmustine vial lots manufactured by BenVenue Laboratories (BVL) are being recalled because of an overfilled vial discovered during stability testing for a single carmustine lot.
- Published
- October 31, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Earth Force, Ltd., Power Towels, QS Plus Hand Sanitizing Wipes (antiseptic), 50 pre-moistened Wipes, Manufactured by: ABC Compounding Co., Inc., P.O. Box 16247, Atlanta, GA 30321.
by Abc Compounding Company Inc
- Reason
- Chemical Contamination: QS Plus wipes were found to be contaminated with different substance (7820, Graffiti Remover).
- Published
- October 31, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Perphenazine Tablets, USP, 8 mg, 100-count tablets per bottle, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-5092-21.
by Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals
- Reason
- Tablet Separation: Possibility of cracked or split coating on the tablets.
- Published
- October 31, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Colloidal Silver, 100 ppm TDS, Natural Mineral Supplement, sold in a) 2 fl.oz (59.15 mL), b) 8 fl.oz (236.6 mL), c) 16 fl.oz (473.2 mL), d) 32 fl.oz (946.4 mL), e) 64 fl.oz (1.89 L), and f) 1 Gal. (3.78 L), Distributed by: Earthborn Products, San Diego, CA 92103.
by Earthborn Products, Inc.
- Reason
- Marketed Without An Approved NDA/ANDA: This product is being recalled because FDA issued a final rule establishing that all over-the-counter (OTC) drug products containing colloidal silver ingredients or silver salts for internal or external use are not generally recognized as safe and effective and are misbranded.
- Published
- October 24, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ NDC 0781-5283-64 --- ALSO sold under Major brand All Day Allergy Children's Cetirizine HCl 5 mg, 5 count blister pack, Major Pharmaceuticals, Livonia, MI NDC 0904-5878-33
by Sandoz Incorporated
- Reason
- Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
- Published
- October 24, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Moexipril HCl Tablets 7.5mg, 100 tabs, Rx Only, Paddock Laboratories, Inc., Minneapolis, MN 55427, NDC 0574-0110-01 ,
by Paddock Laboratories, LLC
- Reason
- Paddock Laboratories, LLC are recalling one lot (2012028142) of Moexipril HCl Tablets 7.5mg (expiration 1/2014) because of a non-conformity dissolution failure result found during routine stability testing at the 6 month test interval.
- Published
- October 17, 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.
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