Estados Unidos Recalls

Cibus Fresh, Sprig & Sprout, and Jack & Olive brand Garden Salad, 7.75oz clear plastic container, UPC 810028250253

Possible Cyclospora Contamination

SYSCO LETTUCE SALAD MIX 4/5# SYSCO LETTUCE SALAD WITH SEP BAG 4/5# Iceberg, Carrots, Red Cabbage products.

Potential Cyclospora contamination.

SYSCO BLEND LETT/ROM 50/50 NOCLR 4/5# SYSCO BLEND LETT/ROM 70/30 NOCOLR 4/5# SYSCO BLEND LETT/ROM 80/20 4/5# Iceberg, Romaine products.

Potential Cyclospora contamination.

MARKON BLEND LETT/ROM 80/20 WITH SEP BAGGIES 4/5# Iceberg, Romaine, Carrots, Red Cabbage products.

Potential Cyclospora contamination.

SYSCO LETTUCE CHOP 4/5# SYSCO LETTUCE SHRED 1/8" 4/5# Iceberg only products.

Potential Cyclospora contamination.

ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000

A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the return path, leading to excessive pressure causing the cryoprobe to rupture.

CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarrytown, NY 10591, a Prestige Consumer Healthcare Company. NDC: 67172-999-01 UPC 6 78112 65920 3

Lack of assurance of sterility. The recall is due to potential contamination

Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC28; 3) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC2C; 4) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC2D; 5) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC2D; 6) KIT, IUS NASAL , Catalog Number: PECGNSBOA; 7) KIT,NASAL FENS, SW , Catalog Number: PEMHNFMHB; 8) KIT,ENT , Catalog Number: PEMIEPHP2; 9) KIT,ENT , Catalog Number: PEMIEPHP3; 10) KIT,ENT , Catalog Number: PEMIEPHPB; 11) KIT, NASAL SINUS P, Catalog Number: PEV2CL016; 12) KIT, ENT FESS , Catalog Number: PEV2FSNYC;

Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

PEAK LETTUCE SALAD W/BAG 4/5# Iceberg, Carrots, Red Cabbage products.

Potential Cyclospora contamination.

B. Braun Medical Inc. Issues Voluntary North American Recall of Excel® Lactated Ringers Injection, 1000mL Due to the Presence of Particulate Matter

Cross Valley Farms LETTUCE CHOP 4/5# Cross Valley Farms LETTUCE SHRED 1/4" 4/5# Cross Valley Farms LETTUCE SHRED 1/8" 4/5# Iceberg only products.

Potential Cyclospora contamination.

Aquafaba Powder, Vegan Replacement, NET WT. 4 oz (113g) and 12 0z (340g), Resealable stand-up matte foil pouch with zipper. UPC 99284 53095 and UPC 99284 30622

Undeclared Egg

TAYLOR FARMS LETTUCE SALAD W/BAG 4/5# Iceberg, Carrots, Red Cabbage products.

Potential Cyclospora contamination.

Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by: Novartis Pharmaceutical Corp, East Hanover, NJ 07936, NDC 0078-0359-34

Failed Dissolution Specifications

Optimal Balance Pharmacy Issues Voluntary Nationwide Recall of Certain Lots of Compounded Glutathione 200 mg/mL Multi-Dose Vials Due to Elevated Endotoxin Levels

SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-08.

CGMP Deviations:Noted during FDA inspection

MARKETSIDE ICEBERG SALAD 10/24 oz, UPC 681131328951; MARKETSIDE ICEBERG SALAD 12/12 oz, UPC 681131328944; MARKETSIDE SHREDDED LETT 12/16 oz, UPC 681131532099; MARKETSIDE SHREDDED LETT 12/8 oz, UPC 681131328968; Iceberg only products.

Potential Cyclospora contamination.

SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-812-03

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202.NDC 71170-712-03

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 1715996-29-5), NDC 85702-002-02.

CGMP Deviations:Noted during FDA inspection

Prince Bakery Inc Issues Allergy Alert on Undeclared Milk and Sesame in Prince Bakery Breads

TAYLOR FARMS LETTUCE CHOP 1X1" 4/4# TAYLOR FARMS LETTUCE CHOP 1X1" 8/2# TAYLOR FARMS LETTUCE CHOP 4/5# TAYLOR FARMS LETTUCE SHRED 1/4" 4/5# TAYLOR FARMS LETTUCE SHRED 1/8" 4/5# TF LETTUCE CHOP .5X.5" 4/5 LB Iceberg only products.

Potential Cyclospora contamination.

SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-822-02

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-002-04.

CGMP Deviations:Noted during FDA inspection