Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

2,152 results found for contamination Page 82 of 87
Mariposa Labs, LLC
Class II Terminated
NorthStar Arthritis Relief Cream. Net Wt. 2 oz tube, OTC, Manufactured for and Distributed by NewMarket Health Products, LLC. 702 Cathedral St. Baltimore, MD 21201
Reason: Microbial Contamination of Non-Sterile Products: Arthritis Relief Cream failed microbiological specifications.
D-462-2014 January 22, 2014 Boise, ID
Tower Pharmacy and Compounding
Class II Terminated
Phenylephrine Nasal 1% Spray, 480 mL bottles, For Office Use, Tower Pharmacy, 26732 Crown Valley Pkwy, Suite 101, Mission Viejo, CA 92691
Reason: Microbial Contamination of Non Sterile Products: Tower Pharmacy is recalling the Phenylephrine Nasal Spray 1% because of possible microbial contamination.
D-384-2014 January 1, 2014 Mission Viejo, CA
Sandoz Incorporated
Class II Terminated
Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz Private ltd. for Sandoz Inc., Princeton, NJ NDC 0781-2102-01
Reason: Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin
D-383-2014 January 1, 2014 Broomfield, CO
Novartis Pharmaceuticals Corp.
Class II Terminated
Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 10/320/25 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Di...
Reason: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tab...
D-330-2014 December 18, 2013 Suffern, NY
Novartis Pharmaceuticals Corp.
Class II Terminated
Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/12.5 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. D...
Reason: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tab...
D-331-2014 December 18, 2013 Suffern, NY
Novartis Pharmaceuticals Corp.
Class II Terminated
Exforge (amlodipine and valsartan Tablets) 5/160 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Nova...
Reason: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tab...
D-328-2014 December 18, 2013 Suffern, NY
Novartis Pharmaceuticals Corp.
Class II Terminated
Diovan (valsartan) 160 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not For Sale, Manufactured by: Novartis Pharmaceuticals Corporation Suffern, NY 10901 for Novartis Pharmaceuticals...
Reason: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tab...
D-326-2014 December 18, 2013 Suffern, NY
Novartis Pharmaceuticals Corp.
Class II Terminated
Diovan (valsartan) 320 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not For Sale, Manufactured by: Novartis Pharmaceuticals Corporation Suffern, NY 10901 for Novartis Pharmaceuticals...
Reason: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tab...
D-327-2014 December 18, 2013 Suffern, NY
Novartis Pharmaceuticals Corp.
Class II Terminated
Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Dis...
Reason: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tab...
D-332-2014 December 18, 2013 Suffern, NY
Novartis Pharmaceuticals Corp.
Class II Terminated
Lescol XL (fluvastatin sodium) Extended-Release Tablets, 80 mg per tablet, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. ...
Reason: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tab...
D-335-2014 December 18, 2013 Suffern, NY
Novartis Pharmaceuticals Corp.
Class II Terminated
Exforge (amlodipine and valsartan, Tablets) 10/320 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: No...
Reason: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tab...
D-334-2014 December 18, 2013 Suffern, NY
Novartis Pharmaceuticals Corp.
Class II Terminated
Exforge (amlodipine and valsartan Tablets) 5/320 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Nova...
Reason: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tab...
D-329-2014 December 18, 2013 Suffern, NY
Novartis Pharmaceuticals Corp.
Class II Terminated
Stalevo (carbidopa, levodopa, and entacapone) 12.5/50/200 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distribut...
Reason: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tab...
D-336-2014 December 18, 2013 Suffern, NY
Novartis Pharmaceuticals Corp.
Class II Terminated
Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 150/12.5 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Di...
Reason: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tab...
D-339-2014 December 18, 2013 Suffern, NY
Novartis Pharmaceuticals Corp.
Class II Terminated
Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 300/25 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Dis...
Reason: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tab...
D-340-2014 December 18, 2013 Suffern, NY
Novartis Pharmaceuticals Corp.
Class II Terminated
Tekturna (aliskiren) Tablets 150 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceu...
Reason: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tab...
D-337-2014 December 18, 2013 Suffern, NY
Novartis Pharmaceuticals Corp.
Class II Terminated
Exforge (amlodipine and valsartan Tablets) 10/160 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Nov...
Reason: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tab...
D-333-2014 December 18, 2013 Suffern, NY
Novartis Pharmaceuticals Corp.
Class II Terminated
Tekturna (aliskiren) Tablets 300 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Produktions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceu...
Reason: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tab...
D-338-2014 December 18, 2013 Suffern, NY
W.S. Badger Company Inc.
Class II Terminated
Badger Kids Broad Spectrum SPF30 Zinc Oxide Sunscreen Lotion Tangerine & Vanilla, 4 fl. oz.. Tube, UPC Code: 634084490145 (US), UPC code: 634084490169 (Canada)
Reason: Microbial Contamination of Non-Sterile Products; Selected lots of Badger Baby and Kids Sunscreen Lotion were recalled due to microbial contamination.
D-325-2014 December 11, 2013 Gilsum, NH
W.S. Badger Company Inc.
Class II Terminated
Badger Baby Broad Spectrum SPF 30 Zinc Oxide Sunscreen Lotion Chamomile & Calendula, 4fFl.oz Tube, UPC code: 634084490091 (US) UPC Code: 634084490114 (Canada)
Reason: Microbial Contamination of Non-Sterile Products; Selected lots of Badger Baby and Kids Sunscreen Lotion were recalled due to microbial contamination.
D-324-2014 December 11, 2013 Gilsum, NH
Sandoz, Inc
Class II Terminated
Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufactured in India by Sandoz Private Ltd, for Sandoz Inc, Princeton, NJ 08540, NDC 0781-5780-92
Reason: Cross contamination with other products: Sandoz is recalling certain lots of Ropinirole Extended Release Tablets 2 mg due to the potential presence of carryover coming from the pre...
D-66458-1 November 13, 2013 Princeton, NJ
Triangle Compounding
Class II Terminated
Histamine, 10 ng/mL Injectable, MDV, Rx only, Triangle Compounding Pharmacy, 3700 Regency Parkway, Suite 140, Cary NC 27518.
Reason: Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test re...
D-1069-2013 October 9, 2013 Cary, NC
Triangle Compounding
Class II Terminated
Sodium Phosphate Injectable, 150mM/50mL Phosphorus 200mEq/50mL Sodium, 50 mL Single Dose Vial, Rx only, Triangle Compounding Pharmacy, 3700 Regency Parkway, Suite 140, Cary NC 27518.
Reason: Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test re...
D-1068-2013 October 9, 2013 Cary, NC
Leiter's Pharmacy
Class II Terminated
Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials, 1 mL Single Use Vial, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126
Reason: Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results...
D-1041-2013 September 25, 2013 San Jose, CA
JCB Labs LLC
Class II Terminated
Acetylcysteine 20% Solution, Preservative Free, 4 mL Sterile Single Dose Vial, Not for Injection, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS.
Reason: Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test r...
D-1043-2013 September 25, 2013 Wichita, KS