Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

2,152 results found for contamination Page 79 of 87
Central Admixture Pharmacy Services, Inc.
Class I Terminated
Robert Wood Johnson University (NJ) Neonatal Starter 5% Dextrose, Trophamine 5%, Dextrose 5%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugat...
Reason: Non-Sterility: Out of specification results for the sterility test for microbial contamination.
D-459-2015 April 15, 2015 Allentown, PA
Central Admixture Pharmacy Services, Inc.
Class I Terminated
Bayshore Medical Center (TX) 10% Dextrose Starter Neo TPN, Trophamine 2.4% , Dextrose 10%, Additives: heparin PF 1 unit(s)/ml, Calcium Gluconate 2.3mEq/dL, compound vol: 250 ml, sterile injectable, Rx...
Reason: Non-Sterility: Out of specification results for the sterility test for microbial contamination.
D-465-2015 April 15, 2015 Allentown, PA
Central Admixture Pharmacy Services, Inc.
Class I Terminated
Advocate Good Samaritan Hospital (IL) TPN Dextrose 10% Trophamine 2%, Trophamine 2% Dextrose 10%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a cor...
Reason: Non-Sterility: Out of specification results for the sterility test for microbial contamination.
D-446-2015 April 15, 2015 Allentown, PA
Central Admixture Pharmacy Services, Inc.
Class I Terminated
Adventist Hinsdale Hospital (IL) Neonatal Starter: Troph 2% Dex10%, Trophamine 2% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 250 ml, sterile injectable, Rx only, compounded drug...
Reason: Non-Sterility: Out of specification results for the sterility test for microbial contamination.
D-444-2015 April 15, 2015 Allentown, PA
Central Admixture Pharmacy Services, Inc.
Class I Terminated
Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag with Calcium, Trophamine 5 gm, Dextrose 10%, Additives: Calcium Gluconate 0.46 mEq/mL, 750mg, compound vol: 250 ml, sterile injectable, Rx ...
Reason: Non-Sterility: Out of specification results for the sterility test for microbial contamination.
D-468-2015 April 15, 2015 Allentown, PA
Tarmac Products, Inc.
Class II Terminated
Antacid Liquid Regular Strength Antacid & Anti-Gas (Aluminum hydroxide 200 mg, Magnesium hydroxide 200 mg, Simethicone 20 mg (in each 5 mL, 1 teaspoon), Mint flavor, 12 fl oz (355 mL) bottle, Distribu...
Reason: Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-month time point.
D-0419-2015 March 25, 2015 Miami Gardens, FL
Fusion Pharmaceuticals, LLC
Class II Terminated
DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) FusePaq, 150 mL Kits, Rx Only. Fusion Pharmaceuticals LLC., 768 Calle Plano, Camarillo, CA 93012. NDC: 43093-104-01.
Reason: Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.
D-0410-2015 March 18, 2015 Camarillo, CA
Akorn, Inc.
Class II Terminated
Erythromycin Pledgets USP, 2%, 60-count jar,Rx only, Manufactured by Ei LLC, Kannapolis, NC 28083, Marketed by VersaPharm Incorporated, Marietta, GA 30062, NDC 61748-202-60 .
Reason: Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests.
D-0385-2015 February 18, 2015 Lake Forest, IL
Valeant Pharmaceuticals North America LLC
Class II Terminated
Virazole (Ribavirin for Inhalation Solution, USP), Sterile Lyophilized For Administration by Aerosol Inhalation Only, Rx only, Contents: Four 6 g vials, 100 mL, Distributed by: Valeant Pharmaceutical...
Reason: Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull.
D-0379-2015 January 28, 2015 Bridgewater, NJ
Tropichem Research Labs, Inc.
Class II Terminated
Entertainer's Secret Throat Relief, 2.0 FL oz (59.2 mL), Honey Apple Flavor, KLI Corp, Carmel, IN
Reason: Microbial Contamination of Non Sterile Product; microbial assay reported unacceptable high plate counts and positive for E. Coli
D-0328-2015 January 7, 2015 Jupiter, FL
Hospira Inc.
Class II Terminated
Meropenem I.V. 1 g is supplied in 30 mL injection vials, RX only. Manufactured by Hospira Healthcare India Pvt. Ltd Tamil Nadu, India for Hospira, Inc. 275 N. Field Drive, Lake Forest, IL 60045. NDC ...
Reason: Defective Container: Glass vials may crack due to low (thin) out of specification vial wall thickness which may lead to contamination and lack of assurance of sterility.
D-0303-2015 December 24, 2014 Lake Forest, IL
Wisconsin Pharmacal Company
Class II Terminated
CVS pharmacy, Pain Relieving Antiseptic Spray. Benzalkonium Cl 0.13% Lidocaine HCl 2.5% 5 FL OZ (148 mL), OTC, Distributed by CVS Pharmacy, Inc., Woonsocket RI 02895 NDC 68093-6150-1
Reason: Microbial Contamination of Non-Sterile Products: CVS Pharmacy Pain Relieving Antiseptic Spray tested positive for microbial growth.
D-0047-2015 November 5, 2014 Jackson, WI
Specialty Compounding, LLC
Class I Terminated
CALCIUM GLUCONATE 2 gm (PF) PRESERVATIVE FREE in 100 mL Sodium Chloride 0.9% for Injection, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613
Reason: Non Sterility: Microbial contamination
D-0230-2015 November 5, 2014 Cedar Park, TX
Janssen Ortho L.L.C.
Class II Terminated
Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99
Reason: Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.
D-0006-2015 October 15, 2014 Gurabo, PR
Apotex Inc.
Class II Terminated
PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3669-3
Reason: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
D-1578-2014 September 10, 2014 Toronto
Apotex Inc.
Class II Terminated
Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3674-3
Reason: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
D-1576-2014 September 10, 2014 Toronto
Apotex Inc.
Class II Terminated
PAXIL (Paroxetine HCL) Tablets 10 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3663-3
Reason: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
D-1580-2014 September 10, 2014 Toronto
Sage Products Inc
Class II Terminated
Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915-80, b) 24 count NDC 53462-915-60, OTC, SAGE PRODUCTS INC., 3909 Three Oaks Road, Cary, IL 60013
Reason: Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.
D-1573-2014 September 10, 2014 Cary, IL
Apotex Inc.
Class II Terminated
PAXIL (Paroxetine HCL) Tablets 20 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3664-3
Reason: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
D-1581-2014 September 10, 2014 Toronto
Apotex Inc.
Class II Terminated
PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL - 250 mL bottle, Rx Only, Manufactured by GlaxoSmithKline, RTP, NC 27709. Distributed by Apotex Corp., Westin, FL 33326, NDC 60505-0402-5
Reason: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
D-1575-2014 September 10, 2014 Toronto
Apotex Inc.
Class II Terminated
PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3670-...
Reason: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
D-1579-2014 September 10, 2014 Toronto
Apotex Inc.
Class II Terminated
Paroxetine HCL Controlled-Release Tablets 12.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3673-3
Reason: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
D-1574-2014 September 10, 2014 Toronto
Apotex Inc.
Class II Terminated
Paroxetine HCL Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3675-3
Reason: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
D-1577-2014 September 10, 2014 Toronto
Apotex Inc.
Class II Terminated
PAXIL (Paroxetine HCL) Tablets 40 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3666-3
Reason: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
D-1582-2014 September 10, 2014 Toronto
Central Admixture Pharmacy Services, Inc.
Class I Terminated
PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
Reason: Non Sterility; microbial contamination identified as Aspergillus species
D-1559-2014 September 3, 2014 Livonia, MI