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Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-870-67
Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-870-67
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-466-05, Unit of Sale NDC Number: 65219-466-60.
0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-466-05, Unit of Sale NDC Number: 65219-466-60.
Lack of Assurance of Sterility
Fresh Cantaloupe (Whole, Fresh), brand name Ayco, wrapped in food safe plastic bags packed in corrugated cardboard cartons; 6-12 melons per box; individual carton count per label. Keep refrigerated; store between 36 40¿F.
Fresh Cantaloupe (Whole, Fresh), brand name Ayco, wrapped in food safe plastic bags packed in corrugated cardboard cartons; 6-12 melons per box; individual carton count per label. Keep refrigerated; store between 36 40¿F.
Potential Salmonella Contamination
0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20.
0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20.
Lack of Assurance of Sterility
Boner Bears Honey Male Enhancement 100% Wildflower Honey, total of 15 pouches per box, Net Wt 15 G each pouch. Dosage: Consume 1 entire pouch 30 minutes before Intercourse. MANUFACTURED IN: FLORIDA. UPC 788362191603
Boner Bears Honey Male Enhancement 100% Wildflower Honey, total of 15 pouches per box, Net Wt 15 G each pouch. Dosage: Consume 1 entire pouch 30 minutes before Intercourse. MANUFACTURED IN: FLORIDA. UPC 788362191603
FDA analysis revealed the presence of undeclared sildenafil and Tadalafil
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: SPECIAL PROCEDURE TRAY, Medline SKU # DYNJ80513B
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: SPECIAL PROCEDURE TRAY, Medline SKU # DYNJ80513B
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-458-05, Unit of Sale NDC Number: 65219-458-30.
5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-458-05, Unit of Sale NDC Number: 65219-458-30.
Lack of Assurance of Sterility
Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC 69097-906-67
Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC 69097-906-67
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436-15 (carton), NDC 0591-2436-45 (blister pack).
Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436-15 (carton), NDC 0591-2436-45 (blister pack).
Superpotent and Subpotent
0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-02.
0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-02.
Lack of Assurance of Sterility
Health Canada warns that Mini T Designer Fireplace and T-Lite 3 Designer Fireplace previously available on Ecosmartfire.ca may pose a risk of fire hazard
Health Canada warns that Mini T Designer Fireplace and T-Lite 3 Designer Fireplace previously available on Ecosmartfire.ca may pose a risk of fire hazard
Fire hazard
Bard Dynamic Deca Steerable Diagnostic EP Catheter and Daig Livewire Steerable Diagnostic EP Catheter
Bard Dynamic Deca Steerable Diagnostic EP Catheter and Daig Livewire Steerable Diagnostic EP Catheter
Sterility
Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max Trial, Cat. No. ARS10252
Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max Trial, Cat. No. ARS10252
Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system.
MicroScan Neg MIC 3J REF C54814
MicroScan Neg MIC 3J REF C54814
Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics
Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5 oz bottles, Mfg: Geri-Care; Brooklyn, New York NDC 68788-7266-0
Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5 oz bottles, Mfg: Geri-Care; Brooklyn, New York NDC 68788-7266-0
Lack of Assurance of Sterility
Zarlengo's Chocolate Gelato packaged in multiple sizes (6 fl oz cups, 16 fl oz cups, 32 fl oz cups and 1-gallon bucket/pail) , Net Wt. 6 fl oz cups - clear freezer grade and round Polyethylene terephthalate cup with peelable paper lid, laminated with heat-sealable plastic, 16 fl oz cups and 32 fl oz cups translucent freezer grade and round High-Density Polyethylene container with lid and 1 Gallon bucket/pail - white round food and freezer grade High-Density Polyethylene bucket/pail with tamper resistant lid.
Zarlengo's Chocolate Gelato packaged in multiple sizes (6 fl oz cups, 16 fl oz cups, 32 fl oz cups and 1-gallon bucket/pail) , Net Wt. 6 fl oz cups - clear freezer grade and round Polyethylene terephthalate cup with peelable paper lid, laminated with heat-sealable plastic, 16 fl oz cups and 32 fl oz cups translucent freezer grade and round High-Density Polyethylene container with lid and 1 Gallon bucket/pail - white round food and freezer grade High-Density Polyethylene bucket/pail with tamper resistant lid.
Soy Lecithin listed in ingredients statement, but Soy is not mentioned in the contains statement.
See Luer Cap Set, MPC-130, set, administration, intravascular
See Luer Cap Set, MPC-130, set, administration, intravascular
Molded Products, Inc. is voluntarily conducting a medical device recall of the MPC-130 See Luer Cap Set based on a confirmed complaint of the threaded sleeve not being engaged and becoming un-attached.
Gutmann Alkoholfreies Hefeweizen, 0,5 Liter, zwei Sorten
Gutmann Alkoholfreies Hefeweizen, 0,5 Liter, zwei Sorten
Sonstige Gründe
Crab Cakes various sizes sold to food service
Crab Cakes various sizes sold to food service
May be temperature abused, which may result in growth of Clostridium botulinum
ReadyMeals Turkey Bacon & Cheddar Pretzel Duo Sandwich, perishable, Keep Refrigerated, plastic clamshell, net wt. 10 oz, UPC 8 26766 25036 3. Distributed By F&S Fresh Foods Vineland, NJ 08360. Label declares CONTAINS EGG, MILK, SOY, WHEAT.
ReadyMeals Turkey Bacon & Cheddar Pretzel Duo Sandwich, perishable, Keep Refrigerated, plastic clamshell, net wt. 10 oz, UPC 8 26766 25036 3. Distributed By F&S Fresh Foods Vineland, NJ 08360. Label declares CONTAINS EGG, MILK, SOY, WHEAT.
Undeclared sesame. Sandwich contains visible sesame but label does not declare sesame.
NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70083007; 2. SYRINGE,8ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70084007; 3. MTS,SYRINGE,8ML,TR/FR,RA,NO,RES,-,P/G, Medline SKU 70084017; 4. SYRINGE,7,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80083007; 5. SYRINGE,8,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80084007; 6. MTO,SYRINGE,8,ML,TR/FR,RA,NO,RES,OEM,PG, Medline SKU 80084017.
NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70083007; 2. SYRINGE,8ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70084007; 3. MTS,SYRINGE,8ML,TR/FR,RA,NO,RES,-,P/G, Medline SKU 70084017; 4. SYRINGE,7,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80083007; 5. SYRINGE,8,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80084007; 6. MTO,SYRINGE,8,ML,TR/FR,RA,NO,RES,OEM,PG, Medline SKU 80084017.
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: MINOR PLASTIC-LF, Medline Kit SKU # DYNJ86596
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: MINOR PLASTIC-LF, Medline Kit SKU # DYNJ86596
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Artri Ajo King tablets
Artri Ajo King tablets
We are advising consumers that Artri Ajo King tablets may pose a serious risk to your health and should not be taken....
SAMYANG Instant Nudeln Scharfes Huhn Carbonara Cup 6 x 80 Gramm
SAMYANG Instant Nudeln Scharfes Huhn Carbonara Cup 6 x 80 Gramm
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