2,152 results found for contamination
Page 84 of 87
West-Ward Pharmaceutical Corp.
Class IITerminated
West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10),Rx only, Manufactured by West-ward Pharmacuetical Corp., Eatontown, N.J., 07724
Reason: Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets contained a trace amount of Methocarbamol.
D-825-2013July 31, 2013Eatontown, NJ
Med Prep Consulting, Inc.
Class IITerminated
All Compounded Products, packaged in plastic infusion bags, devices, syringes and glass vials, Med Prep Consulting Inc., Tinton Falls, NJ 07712
Reason: Lack of Assurance of Sterility; potential for mold contamination
D-811-2013July 31, 2013Tinton Falls, NJ
Med Prep Consulting, Inc.
Class ITerminated
Magnesium Sulfate 2 grams in Dextrose 5% for Injection, in 50 mL Plastic Infusion Bags, Med Prep Consulting Inc., Tinton Falls, NJ 07712
Reason: Non-Sterility; mold contamination
D-810-2013July 31, 2013Tinton Falls, NJ
Vi-Jon, Inc.
Class IIITerminated
ALCOHOL FREE ANTISEPTIC (cetylpyridinium chloride) Mouth Rinse, 0.07%, mint, 33.8 FL OZ (1 L) bottle, Distributed By The Kroger Co., Cincinnati, OH 45202, UPC 0 41260 33606 5.
Reason: Microbial Contamination of Non-Sterile Products: This product is being recalled because a stability sample was found to be contaminated with Burkholderia contaminans.
D-812-2013July 31, 2013Smyrna, TN
Gilead Sciences, Inc.
Class IITerminated
AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only, Single-Use Vial, Rx Only, Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062, Manufactured by: Gilead S...
Reason: Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in some media fill units. No contaminated batches ...
D-821-2013July 31, 2013Foster City, CA
Church & Dwight Inc
Class IITerminated
Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP2 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b)...
Reason: Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
D-798-2013July 24, 2013Princeton, NJ
Church & Dwight Inc
Class IITerminated
Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP5 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b)...
Reason: Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
D-801-2013July 24, 2013Princeton, NJ
Church & Dwight Inc
Class IITerminated
Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, Sodium Bicarbonate U.S.P. No. 4 Granular, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., P...
Reason: Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
D-800-2013July 24, 2013Princeton, NJ
Church & Dwight Inc
Class IITerminated
Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP1 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b)...
Reason: Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
D-797-2013July 24, 2013Princeton, NJ
Church & Dwight Inc
Class IITerminated
Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP3 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b)...
Reason: Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
D-799-2013July 24, 2013Princeton, NJ
Glenmark Generics Inc., USA
Class IIITerminated
Glenmark Pravastatin Sodium Tablets ,40 mg, 90-count bottle (NDC 68462-197-90), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for :Glenmark Generics US...
Reason: Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.
D-330-2013May 22, 2013Mahwah, NJ
Glenmark Generics Inc., USA
Class IIITerminated
Glenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for : Glenmark Generics USA Ma...
Reason: Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature.
D-331-2013May 22, 2013Mahwah, NJ
Glenmark Generics Inc., USA
Class IIITerminated
Glenmark Gabapentin Tablets, a) 600mg, 500- count bottle (NDC 68462-126-05), b) 800 mg, 500- count bottle (NDC 68462-127-05), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 40351...
Reason: Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature.
D-329-2013May 22, 2013Mahwah, NJ
Physicians Total Care, Inc.
Class IIITerminated
Plavix 75 mg, 30 count bottle, NDC (54868-4070-0), Rx only, Manufactured by Bristol-Meyers Squibb, Bridgewater, NJ 08807, Distributed by Physicians Total Care, Tulsa, OK 74146.
Reason: Chemical Contamination: Uncharacteristic moldy odor due to presence of 2,4,6-tribromoanisole (TBA).
D-317-2013May 15, 2013Tulsa, OK
Warner Chilcott Company LLC
Class IIITerminated
Jevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 mcg, 90 count bottle (NDC# 52544-237-19), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Distrib...
Reason: Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
D-304-2013May 8, 2013Fajardo, PR
Warner Chilcott Company LLC
Class IIITerminated
Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, 90 count bottle (NDC#: 0430-0145-23), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Marketed...
Reason: Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
D-303-2013May 8, 2013Fajardo, PR
Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals
Class IITerminated
"Well at Wallgreens" Regular Strength Antacid Liquid (Alumina/Magnesia/Simethicone/Antacid & Anti Gas); Mint, a)12 oz bottle (NDC 0363-0073-02), b) 26 oz. bottle (NDC 0363-0073-26), Distributed by Wal...
Reason: Microbial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count outside of specifications and E. Coli contamination.
D-311-2013May 8, 2013Miami Gardens, FL
Warner Chilcott Company LLC
Class IIITerminated
Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 1.0 mg/5.0 mcg, 90 count bottle ( NDC#: 0430-0544-23), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Marketed ...
Reason: Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
D-305-2013May 8, 2013Fajardo, PR
Sandoz Incorporated
Class IITerminated
Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540, Rx only. Manufactured in 500 ct (NDC 0781-2613-05) and 30 ct (NDC 0781-2613-31) bottles.
Reason: Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.
D-268-2013May 1, 2013Broomfield, CO
Pfizer Inc.
Class IICompleted
Levoxyl (levothyroxine sodium) tablets, USP 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles ( NDC 60793-853-10 ) Rx only, Manufactured and Distributed by: King P...
Reason: Chemical contamination: emission of strong odor after package was opened..
D-254-2013April 24, 2013New York, NY
Pfizer Inc.
Class IICompleted
Levoxyl (levothyroxine sodium) tablets, USP 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b) 1000-count bottles ( NDC 60793-850-10 ) Rx only, Manufactured and Distributed by: King P...
Reason: Chemical contamination: emission of strong odor after package was opened..
D-251-2013April 24, 2013New York, NY
Pfizer Inc.
Class IICompleted
Levoxyl (levothyroxine sodium) tablets, USP 100 mcg, packaged in a) 100-count bottles (NDC 60793-854-01) and b) 1000-count bottles ( NDC 60793-854-10 ) Rx only, Manufactured and Distributed by: King ...
Reason: Chemical contamination: emission of strong odor after package was opened..
D-255-2013April 24, 2013New York, NY
Pfizer Inc.
Class IICompleted
Levoxyl (levothyroxine sodium) tablets, USP 50 mcg, packaged in a) 100-count bottles (NDC 60793-851-01) and b) 1000-count bottles ( NDC 60793-851-10 ) Rx only, Manufactured and Distributed by: King P...
Reason: Chemical contamination: emission of strong odor after package was opened.
D-252-2013April 24, 2013New York, NY
Pfizer Inc.
Class IICompleted
Levoxyl (levothyroxine sodium) tablets, USP 125 mcg, packaged in a) 100-count bottles (NDC 60793-856-01) and b) 1000-count bottles ( NDC 60793-856-10 ) Rx only, Manufactured and Distributed by: King...
Reason: Chemical contamination: emission of strong odor after package was opened
D-257-2013April 24, 2013New York, NY
Pfizer Inc.
Class IICompleted
Levoxyl (levothyroxine sodium) tablets, USP 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles ( NDC 60793-857-10 ) Rx only, Manufactured and Distributed by: King ...
Reason: Chemical contamination: emission of strong odor after package was opened.