Drug and pharmaceutical recalls
17747 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2012-11-14FDA-DrugValeant PharmaceuticalsClass IIIAcneFree 24 Hour Clearing System containing 1-count 4 fl oz (118 mL) Oil-Free Purifying Cleanser (benzoyl peroxide 2.5% w/v) AFCS-0101-00, 1-count 4 fl oz (118 mL) Renewing Toner AFCS-0201-01, and 1-count 2 fl oz (59 mL) Repair Lotion (benzoyl peroxide 3.7% w/v) AFCS-0301-00 per carton, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 12008 6.
Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
- 2012-11-14FDA-DrugAurobindo Pharma LTDClass IINorthstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX, LLC Memphis, TN 38141. Manufactured by Aurobindo Pharma Limited, Unit VII, Mahaboob Dagar, 509302, India
Adulterated Presence of Foreign Tablets: This product is being recalled becaiuse 30 valacyclovir hydrochloride tablets USP 500 mg were discovered in a bottle labeled Zolpidem Tartrate tables USP 10 mg
- 2012-11-14FDA-DrugMerit Medical Systems, IncClass IMerit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.
Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins.
- 2012-11-07FDA-DrugCoral Rock Man, Inc.Class IZ-ROCK All Natural Male Supplement. 1 capsule blister pack, UPC 0 00309 50792 7, Distributed by Zrock USA PO Box 668297, Pompano Beach, FL 33066
Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.
- 2012-11-07FDA-DrugCoral Rock Man, Inc.Class IX-ROCK 3 Day Pill For Men, supplied in 1 and 2 capsule blister packs and 6, 12 and 24 count bottles, UPC 0 00309 50792 7, Distributed by: MATE Enterprises, Miami, Florida 33139, Some labeled as: Manufactured by CRM Laboratories, Distributed by XRock Industries, Ft. Lauderdale, FL, Also, labeled as X-Rock 3 Day Pill For Erectile Refunction, Distributed by www. CoralXRock.Com, Florida Keys, Florida
Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.
- 2012-11-07FDA-DrugXRock Industries, LLCClass IX-ROCK For Men, Dietary Supplement, Manufactured by CRM Laboratories, Distributed by XRock Industries, PO Box 120863, Ft. Lauderdale, FL 33312, 0 00309 50792 7. UPC on labeling is: 0 00309 50792 7. UPC in Press Release is: 0030950792.
Marketed Without an Approved NDA/ANDA: product tested positive for PDE-5 Sildenafil and PDE-5 Hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analog of sildenafil, an FDA approved prescription drug for Erectile Dysfunction (ED).
- 2012-11-07FDA-DrugBen Venue Laboratories IncClass IILeucovorin Calcium Injection USP, single use vials, 10mg/mL; 50mL, Rx only, Manufactured by: Ben Venue Labs, Inc., Bedford, OH 44146, NDC# 55390-009-01(Bedford); NDC# 55390-826-01(Novaplus)
Presence of Particulate Matter: visible crystalline particulates and the discovery of crystalline particulate in a retain sample.
- 2012-11-07FDA-DrugDermaCare, Inc.Class IIUP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Sweet s'melon, 6.7FL oz (200mL), Distributed by Target Corp., Minneapollis, MN 55403
Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification.
- 2012-11-07FDA-DrugDermaCare, Inc.Class IIUP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Apple-cleani, 6.7FL oz (200mL), Distributed by Target Corp., Minneapollis, MN 55403
Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification.
- 2012-10-31FDA-DrugMylan Pharmaceuticals Inc.Class IIDoxazosin Tablets, USP, 2 mg, 100 count bottles, labeled in part ***Manufactured in Australia by: ALPHAPHARM PTY LTD, 15 Garnet Street***Rx Only*** Carole Park QLD 4300, Australia*** Manufactured for Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.SA ***
Cross Contamination w/Other Products: During stability testing chromatographic review revealed extraneous peaks identified as acetaminophen and codeine.
- 2012-10-31FDA-DrugRaritan Pharmaceuticals, Inc.Class IIDRxChoice Fiber Capsules, 25 capsules per bottle, Psyllium Husk Fiber, Mfg. by Raritan Pharmaceuticals, East Brunswick, NJ, UPC 3-68163-11925-1.
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
- 2012-10-31FDA-DrugRaritan Pharmaceuticals, Inc.Class IIPremier Value Fiber Plus Calcium Supplement Capsules, 120 capsules per bottle, Distributed by: Chain Drug Consortium, LLC, Boca Raton, FL, UPC 8-40986-01987-6
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
- 2012-10-31FDA-DrugRaritan Pharmaceuticals, Inc.Class IIPremier Value Fiber Capsules, Fiber Capsules, 100% Natural Psyllium Fiber, Relieves Constipation, Restores Regularity, 160 Capsules per bottle, Distributed by: Chain Drug Consortium, LLC, Boca Raton, FL 33431, UPC0-40986-01703-2
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
- 2012-10-31FDA-DrugRaritan Pharmaceuticals, Inc.Class IISimply Right Healthcare Fiber Capsules, 100% Natural Psyllium Fiber, Fiber Supplement, Fiber Laxative for Regularity, 400 capsules per bottle, Distributed by: SAM'S West, Inc., Bentonville, AR 72716, UPC 0-78742-00524-9.
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
- 2012-10-31FDA-DrugRaritan Pharmaceuticals, Inc.Class IIBerkley & Jensen Fiber Capsules, Fiber Laxative/Fiber Supplement, 100% Natural Psyllium Fiber, 400 capsules per bottle, Distributed by: BJWC, 25 Research Drive, Westborough, MA 01581, Made in USA, UPC 4-00016-27053-2.
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
- 2012-10-31FDA-DrugRaritan Pharmaceuticals, Inc.Class IIWal-Mucil Plus Calcium Fiber Capsules,100% Natural Fiber, 100% Natural Psyllium Seed Husk, Calcium/Dietary Fiber Supplement, 240 Capsules per bottle, Distributed by: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015-4616 www.walgreens.com, NDC 0363-0128-24, UPC 3-11917-07656-0.
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
- 2012-10-31FDA-DrugRaritan Pharmaceuticals, Inc.Class IIWal-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
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
- 2012-10-31FDA-DrugRaritan Pharmaceuticals, Inc.Class IIUp&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.
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
- 2012-10-31FDA-DrugRaritan Pharmaceuticals, Inc.Class IILeader 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.
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
- 2012-10-31FDA-DrugRaritan Pharmaceuticals, Inc.Class IIEquate 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.
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
- 2012-10-31FDA-DrugRaritan Pharmaceuticals, Inc.Class IICVS 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
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
- 2012-10-31FDA-DrugRaritan Pharmaceuticals, Inc.Class IIBest 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
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
- 2012-10-31FDA-DrugHospira Inc.Class IHYDROmorphone 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).
Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfilled and contain more than the 1 mL labeled fill volume.
- 2012-10-31FDA-DrugBristol-myers Squibb CompanyClass IIKombiglyze 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.
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.
- 2012-10-31FDA-DrugBristol-myers Squibb CompanyClass IIKombiglyze 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.
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.
- 2012-10-31FDA-DrugWatson Laboratories IncClass IINecon 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.
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).
- 2012-10-31FDA-DrugWatson Laboratories IncClass IINecon 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.
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).
- 2012-10-31FDA-DrugWatson Laboratories IncClass IIZenchent (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.
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).
- 2012-10-31FDA-DrugWatson Laboratories IncClass IILutera (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.
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).
- 2012-10-31FDA-DrugWatson Laboratories IncClass IIZovia (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.
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).
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