Drugs with Problems July 2, 2014

Drugs	Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg, 30 count bottle, Rx only, Distributed by Wyeth Pharmaceuticals, Inc., NDC 0008-1211-30	H74477, H74478, Exp. 03/16, H74479, H79766 Exp. 05/16	Class II	Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq.	Pfizer Us Pharmaceutical Group
Food	Floribbean Key Lime Calypso Dip 12.5 oz Floribbean 68 SW 40 St. Suite 411 Miami, Florida 33155 1(800)282-8459	Lot # 07171311	Class I	During an FDA inspection a product was found that the label fail to declared the component ingredients of all its compound ingredients like Mayonnaise and Worcestershire sauce that contains allergens like eggs, soy, and anchovies.	Miami Interculinary Center, Inc.
Food	Marissa Collection Tangerine Appetizer Plate Set (set of 2). distributed by Princess House Inc., Taunton, MA	All	Class III	Plates leaching cadmium above the specified acceptable level	Princess House Inc.
Biologics	Platelets Pheresis Leukocytes Reduced	W115114052662T;	Class II	Blood product, labeled as leukoreduced which did not meet the requirements for a leukoreduced product, was distributed.	LifeSouth Community Blood Centers, Inc.
Biologics	Platelets Pooled Leukocytes Reduced	022LF20749;	Class II	Blood products, collected from a donor with a history of an unspecified type of hepatitis, were distributed.	American National Red Cross, Penn Jersey Region
Biologics	Red Blood Cells Leukocytes Reduced	022GC26953; 022GV36632;	Class II	Blood products, collected from a donor with a history of an unspecified type of hepatitis, were distributed.	American National Red Cross, Penn Jersey Region
Biologics	Platelets Leukocytes Reduced	022GV36632;	Class II	Blood products, collected from a donor with a history of an unspecified type of hepatitis, were distributed.	American National Red Cross, Penn Jersey Region
Biologics	Red Blood Cells Leukocytes Reduced	W043214017396;	Class II	Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.	Blood Assurance Inc
Biologics	Platelets	W043214017396;	Class II	Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.	Blood Assurance Inc
Biologics	Blood and Blood Products for Reprocessing	W043214017396;	Class III	Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.	Blood Assurance Inc
Biologics	Red Blood Cells Leukocytes Reduced	W091014122204; W091014116694; W091014122235;	Class II	Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.	Oklahoma Blood Institute - Sylvan N Goldman Center
Biologics	Fresh Frozen Plasma	W035214047404N; W0352140284770; W035214045800V;	Class III	Blood components, incorrectly labeled as units of Fresh Frozen Plasma, were distributed.	Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc
Biologics	Source Plasma	13GWIN5351; 13GWIN5373; 13GWIN5476; 13GWIN4893; 13GWIN5056; 13GWIN1741; 13GWIN1831; 13GWIN1868; 13GWIN1159; 13GWIN1172; 13GWIN1224; 13GWIN1263; 13GWIN0955; 13GWIN0234; 13GWIM8207; 13GWIM8308; 13GWIM8363; 13GWIM8450; 13GWIM3964; 13GWIL9929; 13GWIL9952; 13GWIM0047; 13GWIL9474; 13GWIL9503; 13GWIL8391; 13GWIL8413; 13GWIL8432; 13GWIL8443; 13GWIL6825; 13GWIL6838; 13GWIL6996; 13GWIL7012; 13GWIL6437; 13GWIL6300; 13GWIL1841; 13GWIL1869; 13GWIL0822; 13GWIL0256; 13GWIL0312; 13GWIL0374; 13GWIL0408; 13GWIL0431; 13GWIK9261; 13GWIK9002; 13GWIK9011; 13GWIK9013; 13GWIK9129; 13GWIK8230; 13GWIK8272; 13GWIK8308; 13GWIK8399; 13GWIK8445; 13GWIK7849; 13GWIK7912; 13GWIK7935; 13GWIK7340; 13GWIK7436; 13GWIK7466; 13GWIK6737; 13GWIK6889; 13GWIK6929; 13GWIK5717; 13GWIK5753; 13GWIK5189; 13GWIK5216; 13GWIK5249; 13GWIK5321; 13GWIK5322; 13GWIK5381; 13GWIK5397; 13GWIK4150; 13GWIK4235; 13GWIK4334; 13GWIK3231; 13GWIK3320; 13GWIK2641; 13GWIK2752; 13GWIK1266; 13GWIK1035; 13GWIK1099; 13GWIK1113; 13GWIJ9998; 13GWIK0005; 13GWIK0046; 13GWIK0128; 13GWIK0205; 13GWIK0240; 13GWIK0163; 13GWIJ9620; 13GWIJ9650; 13GWIJ9672;	Class II	Blood products, collected from a donor whose physical examination was incomplete, were distributed.	BioLife Plasma Services, LP
Biologics	Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated	W2038140047151;	Class III	Blood products, labeled with extended expiration dates following irradiation, were distributed.	American Red Cross Blood Svs. Indiana-Ohio Region
Biologics	Red Blood Cells Leukocytes Reduced Irradiated	W203814018447; W203814008716; W203814008718;	Class III	Blood products, labeled with extended expiration dates following irradiation, were distributed.	American Red Cross Blood Svs. Indiana-Ohio Region
Biologics	Red Blood Cells Leukocytes Reduced Irradiated	W203514007225; W203514010120;	Class III	Blood products, labeled with extended expiration dates following irradiation, were distributed.	American Red Cross Greater Alleghenies Region
Biologics	Platelets Pheresis Leukocytes Reduced	W333414000195;	Class II	Blood product, with platelet concentration below the specified minimum requirement, was distributed.	Mississippi Valley Reg Bld Ctr
Biologics	Red Blood Cells Leukocytes Reduced	GY933592029;	Class II	Blood product, incorrectly identified as negative for the Jka antigen, was distributed.	American Natl Red Cross Mid Atlantic Region
Biologics	Cryoprecipitated AHF	W333613096101;	Class II	Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.	Mississippi Valley Reg Bld Ctr
Biologics	Cryoprecipitated AHF, Pooled	W333614009929; W333613078070; W333613058160; W333613041797;	Class II	Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.	Mississippi Valley Reg Bld Ctr
Biologics	Blood and Blood Products for Reprocessing	W333614000431; W333613096101; W333613075416; W333613034870; W333613023898; W33361210579; W333612096602; W333612064894; W333612061393; W333612025384; W333612026028; W333611107126; W333611083733; W333611056590; W333611042891; W333611008496; W333610103997; W333610054350; W333610052033; W333610010309; W038309120873; W038309101325; W038308057636;	Class II	Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.	Mississippi Valley Reg Bld Ctr
Biologics	Red Blood Cells Leukocytes Reduced Irradiated	W200114046137; W200114043726; W200114055183; W203014000716;	Class III	Blood products, labeled with extended expiration dates following irradiation, were distributed.	American National Red Cross, Northeastern Region
Biologics	Platelets Pheresis Leukocytes Reduced Irradiated	W20171480044400;	Class II	Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.	American National Red Cross (The) - North Central Region
Devices	Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting systems), Steris Corporation. Model numbers YG19051 and YG19262.	Model #: YG19051, Serial #'s: 01108340587, 01117338881, 011106337516, 011106337525, 011106337527, 011106337534, 011106337535, 011106337538, 011106337539, 011106337541, 011106337626, 011107338878, 011107338882, 011107338883, 011108340587, 011108340600, 0111073388883 & 011108340600A. Model #: YG19262, Serial #: ART00001 - ART00010, CADS0001 - CADS0015, CBX0001 - CBX0010 & CXSG0008 - CXSG0022.	Class II	Potential for the welded seam in affected monitor spring arms to crack and/or break.	Steris Corporation
Veterinary	LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compatible with T-U- R FLOW-POUCH RESERVOIR, list 6542, 71 inch (180 cm) Nominal Length; List No. 4693-01; single use; Hospira	List No. 4693-04-01 (4693-01); Lot Numbers: 16119NS, 17186NS, 21134NS, 25129NS	Class II	The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543- 01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lead TUR Irrigation Set. Hospira has received complaints of the sterile pack not sealed properly or the Tyvek cover sheet not centered on the bottom tray of the pack.	Hospira Inc.
Veterinary	LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures; 96 inch (244 cm); For Flexible Irrigation Container Systems; List No. 6543-01; single use; Hospira	List No. 6543-04-01 (6543-01); Lot Numbers: 13106NS, 13170NS, 13251NS, 14261NS, 14262NS, 15139NS, 16117NS, 17131NS, 17132NS, 17184NS, 18110NS, 18111NS, 18182NS, 19133NS, 20122NS, 20123NS, 20124NS, 20205NS, 22146NS, 22147NS, 22148NS, 22149NS, 23103NS, 23104NS, 23105NS, 23106NS, 24156NS, 25130NS, 25131NS, 27109NS, 27253NS, 27286NS, 28136NS, 28137NS, 29094NS, 29095NS, 29096NS, 30194NS, 30195NS, 30196NS, 31042NS, 31043NS, 32229NS, 32230NS, 33138NS, 33139NS, 33140NS, 34286NS, 35117NS	Class II	The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543- 01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lead TUR Irrigation Set. Hospira has received complaints of the sterile pack not sealed properly or the Tyvek cover sheet not centered on the bottom tray of the pack.	Hospira Inc.
Veterinary	LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented, 77 inch (195 cm) for Constant or Intermittent Bladder Irrigation; For Use with Flexible Irrigation Container System; List No. 6544- 01; Hospira	List No. 6544-04-01 (6544-01); Lot Numbers: 13107NS, 13108NS, 13171NS, 13172NS, 15141NS, 15142NS, 15143NS, 16113NS, 16114NS, 16115NS, 16116NS, 16174NS, 16175NS, 16176NS, 17134NS, 18112NS, 19130NS, 19131NS, 19132NS, 20119NS, 20120NS, 20121NS, 21130NS, 21131NS, 21207NS, 22144NS, 22145NS, 23107NS, 23108NS, 23109NS, 23110NS, 23111NS, 23112NS, 24194NS, 24204NS, 25133NS, 25254NS, 27110NS, 27111NS, 27155NS, 28192NS, 28271NS, 28272NS, 29097NS, 29170NS, 29171NS, 30197NS, 30198NS, 30199NS, 30200NS, 31044NS, 31045NS, 32231NS, 32232NS, 32391NS, 33328NS, 34170NS, 34170NS, 34171NS, 34287NS, 35115NS, 35116NS, 35250NS, 36160NS	Class II	The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543- 01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lead TUR Irrigation Set. Hospira has received complaints of the sterile pack not sealed properly or the Tyvek cover sheet not centered on the bottom tray of the pack.	Hospira Inc.
Veterinary	LATEX-FREE; LARGE BORE Y-IRRIGATION SET; Nonvented Set; 100 inch (254 cm); For Flexible Irrigation Container Systems; List No. 6599-01; single use; Hospira	List No. 6599-04-01 (6599-01); Lot Numbers:12145NS, 12146NS, 16120NS, 17130NS, 18113NS, 19134NS, 20196NS, 21132NS, 24120NS, 25134NS, 25211NS, 27112NS, 28273NS, 28274NS, 29098NS, 31040NS, 32296NS, 33142NS, 34143NS	Class II	The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543- 01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lead TUR Irrigation Set. Hospira has received complaints of the sterile pack not sealed properly or the Tyvek cover sheet not centered on the bottom tray of the pack.	Hospira Inc.
Veterinary	LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Resection Procedures; 85 inch (216 cm); For Flexible Irrigation Container Systems; List No. 15239-01; Single Use; Hospira	List No. 15239-04-01 (15239-01); Lot Numbers: 13259NS, 17185NS, 18181NS, 23102NS, 27108NS, 28275NS, 29093NS, 31041NS	Class II	The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543- 01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lead TUR Irrigation Set. Hospira has received complaints of the sterile pack not sealed properly or the Tyvek cover sheet not centered on the bottom tray of the pack.	Hospira Inc.
Biologics	Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated	W20171401320400;	Class III	Blood product, labeled with an extended expiration date following irradiation, was distributed.	American National Red Cross
Biologics	Red Blood Cells Leukocytes Reduced Irradiated	W201314035722; W201314029759;	Class III	Blood products, labeled with extended expiration dates following irradiation, were distributed.	American National Red Cross Southeastern Michigan Region
Biologics	Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated	W2013140135461; W2013140135462;	Class III	Blood products, labeled with extended expiration dates following irradiation, were distributed.	American National Red Cross Southeastern Michigan Region
Biologics	Red Blood Cells Leukocytes Reduced Irradiated	W20061403227700;	Class III	Blood product, labeled with an extended expiration date following irradiation, was distributed.	American National Red Cross The
Drugs	Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd, Gujarat, India, NDC 47335-154-40	JKM7188A	Class II	Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.	Caraco Pharmaceutical Laboratories, Ltd.
Drugs	Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-0953-02.	Lot # 34013122A, Exp 11/15	Class II	Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing.	Teva Pharmaceuticals USA
Biologics	Red Blood Cells Leukocytes Reduced Irradiated	W201614025133; W201614021528;	Class III	Blood products, labeled with extended expiration dates, were distributed.	American National Red Cross Great Lakes Region
Biologics	Red Blood Cells (Apheresis) Leukocytes Reduced	W2017140103561; W2017140103562; W2017140022701; W2017140022702; W2017140103482; W2017140926511; W2017140103481;	Class II	Blood products, collected from a donor whose health history screening was not adequately performed, were distributed.	American National Red Cross (The) - North Central Region
Biologics	Red Blood Cells Leukocytes Reduced	W201714002238; W201714002285; W201714002302; W201714033688; W201714063660; W201714063679; W201714007695; W201714011356; W201714095155; W201714095285; W201714097435; W201714097483; W201714085287; W201714085316; W201714005926; W201714002059; W201714002068; W201714002133; W201714002155; W201714002157; W201714001659;	Class II	Blood products, collected from a donor whose health history screening was not adequately performed, were distributed.	American National Red Cross (The) - North Central Region
Devices	LAP LASER PICTOR 3D Multi Color Laser System PICTOR 3D is a LAP laser system which uses multi projection format that defines isocenters, field and MLC contours along with a 3D patient view.	Product Code: 0007569-0001	Class II	While projecting yellow lines it was notice that the yellow projection has the potential to splits into two separate red and green projections. In this case the difference between the red and green projection was up to 2.5mm.	LAP of America Laser Applications, LLC
Biologics	Red Blood Cells (Apheresis) Leukocytes Reduced	W041013144667G; W041013144667G;	Class III	Blood products, positive for the M-antigen but labeled negative for the M-antigen, were distributed.	United Blood Services
Biologics	Red Blood Cells	W121614125163;	Class III	Blood product, collected from a donor with an unacceptable temperature, was distributed.	The Blood Connection, Inc.
Devices	Accell® Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160. Product Usage: Accell Evo3c Demineralized Bone Matrix Putty is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. Accell Evo3c is indicated for use as a bone graft extender in the spine, extremities and pelvis, or as a bone void filler in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.	Model Number: 02-6000-050 , Lot Number: 132160.	Class II	This lot (132160) of Accell Evo3C Demineralized Bone Matrix, 5cc was incorrectly packaged in boxes that describe the product as Accell Evo3 Demineralized Bone Matrix. Evo3C is contraindicated for treatment of vertebral compression and not indicated for use in the posterolateral spine.	Integra LifeSciences Corp.
Devices	Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.	LOTS#: N060208K, N060209K, N0602010K, N0902014K, N0902015K, N0902016K, N0902017K, N0902018K, N0902019K, N0902020K, N1102021K, N1102022K, N1102023K, N1102024K, N1102025K, N1102026K, N1102027K, N1102028K, N1102029K.	Class II	JAS Diagnostics, Inc. of Miami Lakes, FL is recalling their Glucose Hexokinase reagent due to certain lots not performing according to their specifications.	JAS Diagnostics Inc.
Drugs	Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%, packaged in a) 1 g tube per carton, professional sample, NDC 24208-385-01, UPC 3 24208-385-01 2; b) 1/8 oz. (3.5 g) tube per carton, NDC 24208-385-55, UPC 3 24208-385-55 5; and c) 1/4 oz. (7 g) Twin Pack, Two 1/8 oz. (3.5 g) tubes per carton, NDC 24208-385-56, UPC 3 24208-385-56 3; Bausch & Lomb Incorporated, Tampa, FL 33637.	Lot #: a) 179271, Exp 08/14; b) and c) 146791, 146932, Exp 06/14; 151221, 151922, Exp 09/14; 159102, Exp 02/15; 160912, Exp 03/15; 162422, Exp 04/15; 163641, 05/15; 166592, Exp 07/15; 169273, Exp 09/15; 170482, Exp 10/15; 174882, Exp 12/15; 176932, Exp 01/16; 179272, Exp 02/16; 182772, Exp 05/16; 186722, Exp 07/16; 190182, Exp 09/16; and 191631, Exp 10/16	Class II	Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.	Bausch & Lomb, Inc.
Drugs	Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, 1/8 oz. (3.5 g) tube per carton, Distributed by Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-5315-38, UPC 3 09045 31538 5.	Lot #'s: 159101, Exp 02/15; 169271, Exp 09/15; and 170481, Exp 10/15	Class II	Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.	Bausch & Lomb, Inc.