2,152 results found for contamination
Page 81 of 87
Terra-Medica Inc.
Class IITerminated
Pleo Not TABLETS 5X, 20 Tablet Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck Gm...
Reason: Penicillin Cross Contamination
D-1194-2014April 16, 2014Ferndale, WA
Terra-Medica Inc.
Class IITerminated
Pleo Fort CAPSULES 4X, 20 Capsule Cartons Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC:...
Reason: Penicillin Cross Contamination
D-1205-2014April 16, 2014Ferndale, WA
Terra-Medica Inc.
Class IITerminated
Pleo-Fort DROPS 5X, 10ml bottle, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-11...
Reason: Penicillin Cross Contamination
D-1207-2014April 16, 2014Ferndale, WA
Terra-Medica Inc.
Class IITerminated
Pleo Stolo DROPS 6X, 10ml Bottle; Homeopathic Anti-Inflammatory Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49...
Reason: Penicillin Cross Contamination
D-1212-2014April 16, 2014Ferndale, WA
Terra-Medica Inc.
Class IITerminated
Pleo Not OINTMENT 3X, 30 g Tube, Topical Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH &...
Reason: Penicillin Cross Contamination
D-1191-2014April 16, 2014Ferndale, WA
Terra-Medica Inc.
Class IITerminated
Pleo Not PORTABLE SIPS, 6X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlb...
Calcium Gluconate 10% for Injection, SDV 100 mL SDV, PF, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ, 85205.
Reason: Non-Sterility: RX Formulation initiated this recall due to a report of microbial contamination found in Calcium Gluconate saturated solution that was observed upon drawing the vial...
D-1213-2014April 16, 2014Mesa, AZ
Terra-Medica Inc.
Class IITerminated
Pleo Fort PORTABLE SIPS 5X, 10 x 1 mL Carton. Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 498...
Reason: Penicillin Cross Contamination.
D-1206-2014April 16, 2014Ferndale, WA
Terra-Medica Inc.
Class IITerminated
Pleo Ex PORTABLE SIPS 5X, 10 x 1 mL, Oral Homeopathic Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp. 1465 Slator Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH ...
Reason: Penicillin Cross Contamination
D-1211-2014April 16, 2014Ferndale, WA
Terra-Medica Inc.
Class IITerminated
Pleo Not PORTABLE SIPS 7X,10 x 1 mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlb...
Reason: Penicillin Cross Contamination
D-1198-2014April 16, 2014Ferndale, WA
Terra-Medica Inc.
Class IITerminated
Pleo Not SUPPOSITORIES 3X, 10 Suppository Cartons, Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlb...
Reason: Penicillin Cross Contamination
D-1192-2014April 16, 2014Ferndale, WA
Terra-Medica Inc.
Class IITerminated
Pleo Not CAPSULES 4X, 20 Tablet Cartons, Oral Homeopathic Fever Reducer/ Cough Suppressant/ Decongestant Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadal...
Reason: Penicillin Cross Contamination
D-1193-2014April 16, 2014Ferndale, WA
Terra-Medica Inc.
Class IITerminated
Pleo Ex DROPS 5X, 10 ml bottles, Homeopathic Antifungal Medicine, OTC Only. Made in Germany for: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GMbH & Co. KG. NDC: 49807-1003...
Reason: Penicillin Cross Contamination
D-1210-2014April 16, 2014Ferndale, WA
Terra-Medica Inc.
Class IITerminated
Pleo Ex SUPPOSITORIES 3X, 10 Suppository Packages; Homeopathic Antifungal Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by:...
Reason: Penicillin Cross Contamination
D-1209-2014April 16, 2014Ferndale, WA
Terra-Medica Inc.
Class IITerminated
Pleo Not DROPS, 5X, 10 mL Bottles, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & ...
Reason: Penicillin Cross Contamination
D-1195-2014April 16, 2014Ferndale, WA
Terra-Medica Inc.
Class IITerminated
Pleo Fort SUPPOSITORIES 3X, 10 Suppository Carton, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co...
Reason: Penicillin Cross Contamination
D-1204-2014April 16, 2014Ferndale, WA
Terra-Medica Inc.
Class IITerminated
Pleo Quent SUPPOSITORIES 3X, 10 Suppository Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. ND...
Reason: Penicillin Cross Contamination
D-1200-2014April 16, 2014Ferndale, WA
Terra-Medica Inc.
Class IITerminated
Pleo Quent CAPSULES 4X, 20 Capsule Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG NDC: 49807-2...
Reason: Penicillin Cross Contamination
D-1201-2014April 16, 2014Ferndale, WA
Viiv Healthcare Company
Class IIITerminated
Tivicay (dolutegravir) Tablets 50 mg, 30 Tablet Bottles, Rx Only. Manufactured for: ViiV Health, TRP, NC 27709; by: GlaxoSmithKline, Research Triangle Park, NC 27709. Made in Japan. NDC 49702-228-13
Reason: Cross Contamination with Other Products: Product contains Promacta (eltrombopag).
D-1185-2014April 9, 2014Durham, NC
Dr. Reddy's Laboratories, Inc.
Class IITerminated
a) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Dist by Walgreen Company, 200 Wilmot RD Deerfield IL 60015 b) Family Wellness Lansoprazole Delayed ...
Reason: Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count were observed at the initial stability interval for Lansoprazole Delayed Release C...
D-1146-2014March 12, 2014Princeton, NJ
Faria Limited LLC dba Sheffield Pharmaceuticals
Class IITerminated
Dollar General Triple Antibiotic Ointment; NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY DOLGENCORP LLC, GOODLETTSVILLE, TN 37072
Reason: Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
D-1078-2014February 12, 2014New London, CT
Faria Limited LLC dba Sheffield Pharmaceuticals
Class IITerminated
FAMILY wellness Triple Antibiotic Ointment. NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC., MATTHEWS,NC 28105
Reason: Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
D-1077-2014February 12, 2014New London, CT
Fusion Pharmaceuticals, LLC
Class IITerminated
Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML
Reason: Microbial Contamination of Non-Sterile Products: Fusion Pharmaceuticals is recalling the Dicopanol FusePaq Kit due to Total Yeasts and Molds Count above USP limits.
D-1055-2014February 12, 2014Camarillo, CA
Faria Limited LLC dba Sheffield Pharmaceuticals
Class IITerminated
Dr. Sheffield Triple Antibiotic Ointment, OTC a) 0.33 oz (9g) (NDC 11527-162-47); b) 1 oz (22g) (NDC 11527-163-55) SHEFFIELD PHARMACEUTICALS, New London, CT 06320
Reason: Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
D-1076-2014February 12, 2014New London, CT
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. Aqueous solution. Active Ingredients Benzalkonium ch...
Reason: Microbial Contamination of Non-Sterile Product(s): The product was found to be contaminated with Bulkholderia sp.