2,152 results found for contamination
Page 85 of 87
Pfizer Inc.
Class IICompleted
Levoxyl (levothyroxine sodium) tablets, USP 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count bottles ( NDC 60793-855-10 ) Rx only, Manufactured and Distributed by: King ...
Reason: Chemical contamination: emission of strong odor after package was opened.
D-256-2013April 24, 2013New York, NY
Pfizer Inc.
Class IICompleted
Levoxyl (levothyroxine sodium) tablets, USP 75 mcg, packaged in a) 100-count bottles (NDC 60793-852-01) and b) 1000-count bottles ( NDC 60793-852-10 ) Rx only, Manufactured and Distributed by: King ...
Reason: Chemical contamination: emission of strong odor after package was opened.
D-253-2013April 24, 2013New York, NY
Pfizer Inc.
Class IICompleted
Levoxyl (levothyroxine sodium) tablets, USP 175 mcg, packaged in a) 100-count bottles (NDC 60793-859-01) and b) 1000-count bottles ( NDC 60793-859-10 ) Rx only, Manufactured and Distributed by: King ...
Reason: Chemical contamination: emission of strong odor after package was opened.
D-260-2013April 24, 2013New York, NY
Pfizer Inc.
Class IICompleted
Levoxyl (levothyroxine sodium) tablets, USP 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles ( NDC 60793-858-10 ) Rx only, Manufactured and Distributed by: King ...
Reason: Chemical contamination: emission of strong odor after package was opened.
D-259-2013April 24, 2013New York, NY
Pfizer Inc.
Class IICompleted
Levoxyl (levothyroxine sodium) tablets, USP 200 mcg, packaged in a) 100-count bottles (NDC 60793-860-01) and b) 1000-count bottles ( NDC 60793-860-10 ) Rx only, Manufactured and Distributed by: King ...
Reason: Chemical contamination: emission of strong odor after package was opened.
D-261-2013April 24, 2013New York, NY
Dr Reddys Laboratories Tennessee LLC
Class IITerminated
Amoxicillin for Oral Suspension, 125mg/5mL, a) 80 mL (NDC 43598-222-80); b) 100mL, (NDC 43598-222-52); c)150 mL (NDC 43598-222-53) bottles, Rx only, Dist. By: Dr. REDDY'S Laboratories, Inc., Bridgew...
Reason: Microbial Contamination of Non-Sterile Products: Suspensions made from these lots of Amoxicillin 125 mg/5 mL showed yeast and mold growth at the 14 day time point.
D-239-2013April 10, 2013Bristol, TN
Humco Holding Group, Inc
Class IITerminated
Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and relieves pain and itching of minor cuts, scrapes, burns and insect bites. Active Ingredients Benzalkonium chloride 0.13% - Fir...
Reason: Microbial Contamination of Non-Sterile Product(s): The product has the potential to be contaminated with Bulkholderia gladioli.
D-197-2013March 20, 2013Texarkana, TX
Glenmark Generics Inc., USA
Class IIITerminated
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 Generi...
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 mo...
D-182-2013March 13, 2013Mahwah, NJ
Dr. Reddy's Laboratories, Inc.
Class IITerminated
Citalopram tablets USP, 40mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-344-30
Reason: Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.
D-180-2013March 6, 2013Bridgewater, NJ
Dr. Reddy's Laboratories, Inc.
Class IITerminated
Citalopram tablets USP, 20mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-343-30
Reason: Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.
D-179-2013March 6, 2013Bridgewater, NJ
Dr. Reddy's Laboratories, Inc.
Class IITerminated
Citalopram tablets USP, 10mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-342-30
Reason: Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.
D-178-2013March 6, 2013Bridgewater, NJ
Procter & Gamble Hair Care Llc
Class IIITerminated
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
Reason: Cross Contamination with Other Products: Product was mixed with another type of mouth wash.
D-167-2013February 27, 2013Iowa City, IA
Lee Pharmaceuticals, Inc
Class IITerminated
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 ...
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.
D-161-2013February 20, 2013South El Monte, CA
Matrixx Initiatives Inc
Class ITerminated
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 o...
Reason: Microbial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia cepacia.
D-155-2013February 13, 2013Scottsdale, AZ
Hillyard GMP
Class IITerminated
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
Reason: Microbial Contamination of Non-Sterile Products: The product may be contaminated with bacteria.
D-140-2013February 6, 2013Saint Joseph, MO
American Enterprises LLC dba Sterling Gelatin
Class IITerminated
Limed Bone Gelatin, packaged in six 125 kg fiber drums and labeled in part PO NO.: P8095 GELATIN 75 BLOOM ITEM NO. RM 164. MADE IN INDIA
Reason: Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
D-062-2013November 28, 2012Prince George, VA
DermaCare, Inc.
Class IITerminated
UP & 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
Reason: Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification.
D-035-2013November 7, 2012Sarasota, FL
DermaCare, Inc.
Class IITerminated
UP & 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
Reason: Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification.
D-034-2013November 7, 2012Sarasota, FL
Watson Laboratories Inc
Class IITerminated
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, I...
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 Hydrochl...
D-015-2013October 31, 2012Corona, CA
Raritan Pharmaceuticals, Inc.
Class IITerminated
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, ...
Reason: Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
D-025-2013October 31, 2012East Brunswick, NJ
Raritan Pharmaceuticals, Inc.
Class IITerminated
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: Walgr...
Reason: Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
D-026-2013October 31, 2012East Brunswick, NJ
Watson Laboratories Inc
Class IITerminated
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 ...
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 Hydrochl...
D-013-2013October 31, 2012Corona, CA
Raritan Pharmaceuticals, Inc.
Class IITerminated
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
Reason: Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
D-022-2013October 31, 2012East Brunswick, NJ
Watson Laboratories Inc
Class IITerminated
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, Manufactur...
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 Hydrochl...
D-016-2013October 31, 2012Corona, CA
Watson Laboratories Inc
Class IITerminated
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...
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 Hydrochl...