Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

2,152 results found for contamination Page 52 of 87
VistaPharm, Inc.
Class II Terminated
Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-01
Reason: Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
D-1053-2017 August 9, 2017 Largo, FL
VistaPharm, Inc.
Class II Terminated
Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-50
Reason: Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
D-1052-2017 August 9, 2017 Largo, FL
Sigan Industries Inc.
Class II Terminated
CVS Health Baby Eczema Moisturizing Cream(colloidal oatmeal 1.0%), Net Wt. 7.3 oz (207g) tubes, OTC, Distributed by CVS Pharmacy Inc., Woonsocket, RI --- UPC 050428568033
Reason: Microbial Contamination of Non Sterile Products; out of specification Total Plate Count
D-0975-2017 July 19, 2017 Brampton
Sandoz Incorporated
Class III Terminated
Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-1487-01) and b) 1000-count bottles ( NDC 0781-1487-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540
Reason: Cross Contamination With Other Product: Imipramine
D-0943-2017 July 12, 2017 Broomfield, CO
Bausch & Lomb, Inc.
Class II Terminated
NasalCrom (cromolyn sodium) Nasal Spray, USP, 5.2 mg per spray, 200 metered sprays, 0.88 FL OZ (26 mL) metered spray pump bottle, Distributed by: Medtech Products, Inc., Tarrytown, NY 10591, UPC 8 14...
Reason: CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
D-0899-2017 June 21, 2017 Tampa, FL
Mylan Pharmaceuticals Inc.
Class III Terminated
Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 1 blister pack containing 28 tablets (NDC 50102-128-01), packaged in 3 pouches, each pouch conta...
Reason: Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair...
D-0860-2017 May 31, 2017 Morgantown, WV
Mylan Pharmaceuticals Inc.
Class III Terminated
Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 blister pack containing 21 tablets (NDC 0378-7280-85), packaged in 3 pouches, each contains one blister pack of 21 tablets (ND...
Reason: Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair...
D-0861-2017 May 31, 2017 Morgantown, WV
Taro Pharmaceuticals U.S.A., Inc.
Class III Terminated
Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, N...
Reason: Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.
D-0790-2017 May 24, 2017 Hawthorne, NY
Teva Pharmaceuticals USA
Class II Terminated
Clozapine Tablets USP, 25 mg, 100-count bottle (NDC 0093-4359-01), 500- count bottle (NDC 0093-4359-05), 100 Unit Dose Blisters per carton (NDC 0093-4359-93), Individual Blister Pack (NDC 0093-4359-19...
Reason: Microbial Contamination of Non-Sterile Products
D-0705-2017 May 17, 2017 North Wales, PA
Signature Club A Ltd
Class II Ongoing
Double Hyaluronic 1000, 'AN OUNCE OF GOLD' Volumizing Day Cream, Broad Spectrum SPF 30+, (Octinoxate 7.725%, Oxybenzone 6.18%, Octisalate 5.15%, Avobenzone 3.09%), Net Wt. 1.8 oz. (51 g) jar, Distribu...
Reason: Microbial Contamination of Non-Sterile Products: odor complaint of product due to microbial contamination.
D-0662-2017 April 19, 2017 Tampa, FL
Novel Laboratories, Inc.
Class III Terminated
Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only, Manufactured for Gavis Pharmaceuticals, LLC, Somerset NJ 08873, Manufactured b...
Reason: Chemical Contamination
D-0653-2017 April 19, 2017 Somerset, NJ
Alvogen, Inc
Class III Terminated
Adalat CC (nifedipine) Extended Release Tablets 30 mg, 100-count bottles, Rx only, Manufactured for Bayer Healthcare Bayer Healthcare Pharmaceuticals Inc. Whippany, NJ 07901 Manufactured in Germany, ...
Reason: Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
D-0628-2017 April 12, 2017 Pine Brook, NJ
Alvogen, Inc
Class III Terminated
Nifedipine Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-370-01.
Reason: Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
D-0631-2017 April 12, 2017 Pine Brook, NJ
Alvogen, Inc
Class III Terminated
Adalat CC (nifedipine) Extended Release Tablets, 60 mg, 100- count bottles, Rx only Manufactured for Almatica, Almatica Pharma Inc. Pinebrook, NJ 07058 USA, NDC 50419-702-05
Reason: Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
D-0629-2017 April 12, 2017 Pine Brook, NJ
Alvogen, Inc
Class III Terminated
Nifedipine Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-368-01.
Reason: Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
D-0627-2017 April 12, 2017 Pine Brook, NJ
Alvogen, Inc
Class III Terminated
Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-369-01.
Reason: Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
D-0630-2017 April 12, 2017 Pine Brook, NJ
Alvogen, Inc
Class III Terminated
Adalat CC (nifedipine) Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749401
Reason: Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
D-0633-2017 April 12, 2017 Pine Brook, NJ
Alvogen, Inc
Class III Terminated
Adalat CC (nifedipine) Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749501
Reason: Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
D-0634-2017 April 12, 2017 Pine Brook, NJ
Alvogen, Inc
Class III Terminated
Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749601
Reason: Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
D-0635-2017 April 12, 2017 Pine Brook, NJ
Dr. Reddy's Laboratories, Inc.
Class III Terminated
RIVASTIGMINE Tartrate Capsules, USP, 1.5 mg, 60-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally 500-900 India, NDC 55111-352-60
Reason: Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine.
D-0649-2017 April 12, 2017 Princeton, NJ
Alvogen, Inc
Class III Terminated
Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 50419-70305
Reason: Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
D-0632-2017 April 12, 2017 Pine Brook, NJ
Mylan Pharmaceuticals Inc.
Class II Terminated
Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b) 500-count bottles (NDC 0378-3953-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Reason: Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
D-0621-2017 April 5, 2017 Morgantown, WV
Claris Lifesciences Inc
Class II Terminated
Metronidazole Injection, USP, 500 mg/100 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-001-24
Reason: Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
D-0616-2017 April 5, 2017 North Brunswick, NJ
Mylan Pharmaceuticals Inc.
Class II Terminated
Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09) and b) 500-count bottles (NDC 0378-3951-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Reason: Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
D-0619-2017 April 5, 2017 Morgantown, WV
Claris Lifesciences Inc
Class II Terminated
Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-003-06
Reason: Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
D-0614-2017 April 5, 2017 North Brunswick, NJ