United States Recalls

CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-603-51

Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.

SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-810-01

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

SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-722-02

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

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

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

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

Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container, Frozen Premix, Sterile, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-3508-41.

Presence of Particulate Matter

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

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

Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebel-Flarsheim Company LLC, Raleigh, NC 27616, Made in USA, NDC 0019-1333-65.

Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.

SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-495-05

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

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

Grade A Brown In-shell Chicken eggs packaged in the following configurations: 1. Simple Truth, Natural Cage Free Grain Fed, Medium, 12 Eggs, Net Wt 21 oz (1lb 5oz) 596g, UPC 0 11110-87032 0. Distributed by The Kroger Co., Cincinnati, OH 45202. 2. Simple Truth, Natural Cage Free Grain Fed, Large, 12 Eggs, Net Wt 24 oz (1lb 8oz) 681g, UPC 0 11110-79770 4. Distributed by The Kroger Co., Cincinnati, OH 45202. 3. Simple Truth, Natural Cage Free Grain Fed, Large, 18 Eggs, Net Wt 36 oz (2lb 4oz) 1,031g, UPC 0 11110-89310 9. Distributed by The Kroger Co., Cincinnati, OH 45202. 4. Simple Truth, Natural Cage Free Grain Fed, Large, 24 Eggs, Net Wt 48 oz (3lb) 1,360g, UPC 0 11110-15097 4. Distributed by The Kroger Co., Cincinnati, OH 45202. 5. Grade A CFB Large Egg, Bulk - BROWN, TICTAC, 900 doz, Distributed by MPS Egg Farms 14374 E State Hwy 21, Byran, TX 77808. Keep Refrigerated.

Possible Salmonella Enteritidis

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

Potential Cyclospora contamination.

Kian Pee Wan Capsules, 30-count bottles

Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.

SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-811-02

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

Honeyville YELLOW COLOR 1 GALLON NFI: WATER, FD&C YELLOW #5, FD&C YELLOW #6, CITRIC ACID, AND SODIUM BENZOATE. MANUFACTURED FOR: HONEYVILLE, INC. RANCHO CUCAMONGA, CA 91730

Undeclared Red #40.

Vodka Tomato Sauce, NET WT. 24 oz / 680g, glass jar packed 12 jars in a carton.

Label declares cream and cheese, but Milk is not declared

SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-721-01

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

SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-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, Mahesana, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-05

CGMP Deviations:Noted during FDA inspection

GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.

10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).

Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl Alcohol 1.5%, Na Hydroxide (Ph Adjust) in sterile water for injection, VMC.

Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.

SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-711-02

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

Grade A White In-shell Chicken eggs packaged in the following configurations: 1. Kroger, Medium, 12 Eggs, Net Wt 21 oz (1lb 5oz) 596g, UPC 0 11110-60902 1. Distributed by The Kroger Co., Cincinnati, OH 45202. 2. Kroger, Medium, 30 Eggs, Net Wt 52.5 oz (3lb 4.5oz) 596g, UPC 0 11110-60980 9. Distributed by The Kroger Co., Cincinnati, OH 45202. 3. Kroger, Large 12 Eggs, Net Wt 24 oz (1lb 8oz) 681g, UPC 0 11110-60903 8. Distributed by The Kroger Co., Cincinnati, OH 45202. 4. Kroger, Large 18 Eggs, Net Wt 36 oz (2lb 4oz) 1.03kg, UPC 0 11110-60933 5. Distributed by The Kroger Co., Cincinnati, OH 45202. 5. Kroger, Large 60 Eggs, Net Wt 7lb 8oz (3.40kg), UPC 0 11110-60933 5. Distributed by The Kroger Co., Cincinnati, OH 45202. 6. Kroger, Extra Large 12 Eggs, Net Wt 27 oz (1lb 11oz) 766g, UPC 0 11110-60904 5. Distributed by The Kroger Co., Cincinnati, OH 45202. 7. Kroger, Jumbo 12 Eggs, Net Wt 30 oz (1lb 14oz) 851g, UPC 0 11110-60905 2. Distributed by The Kroger Co., Cincinnati, OH 45202. Packed by Tx Lic #613171, 800 Wabash Rd, N. Manchester, IN 46962. 8. Brookshire's farm fresh, Large 6 Eggs, Net Wt 12 oz (341g), UPC 0 92825-09564 4. Distributed by: Brookshire Grocery Company, P.O. Box 1411, Tyler, TX 75710-1411. 9. Brookshire's farm fresh, Large 12 Eggs, Net Wt 24 oz (1lb 8oz) 681g, UPC 0 92825-09555 2. Distributed by: Brookshire Grocery Company, P.O. Box 1411, Tyler, TX 75710-1411. 10. Brookshire's farm fresh, Large 18 Eggs, Net Wt 36 oz (2lb 4oz) 1.03kg, UPC 0 92825-09556 9. Distributed by: Brookshire Grocery Company, P.O. Box 1411, Tyler, TX 75710-1411. 11. Brookshire's farm fresh, Large 36 Total Eggs TWIN PACK (18 Each), Net Wt 36 oz (2lb 4oz) 1.03kg, UPC 0 92825-10980 8. Distributed by: Brookshire Grocery Company, P.O. Box 1411, Tyler, TX 75710-1411. 12. Super 1 Foods Large 60 Eggs, Net Wt 120 oz (7lbs8oz) 3.4kg, UPC 0 92825-09563 7. Distributed by: Brookshire Grocery Company, P.O. Box 1411, Tyler, TX 75710-1411. 13. Brookshire's farm fresh, Extra Large 18 Eggs, Net Wt 40.5 oz (2lb 8.5oz) 1.15kg, UPC 0 92825-09560 6. Distributed by: Brookshire Grocery Company, P.O. Box 1411, Tyler, TX 75710-1411. 14. Brookshire's farm fresh, Jumbo 12 Eggs, Net Wt 30 oz (1lb 14oz) 851g, UPC 0 92825-09558 3. Distributed by: Brookshire Grocery Company, P.O. Box 1411, Tyler, TX 75710-1411. Packed by MPS Egg Farms, 14374 E State Hwy 21, Byran, TX 77808. 15. Country Morning Medium 12 Eggs, Net Wt 21 oz (1lb 5oz) 596g, UPC 0 78566-00104 5. 16. Country Morning Large 12 Eggs, Net Wt 24 oz (1lb 8oz) 681g, UPC 0 78566-20000 4. 17. Country Morning Large 18 Eggs, Net Wt 36 oz (2lb 4oz) 1.03kg, UPC 0 78566-00503 6. 18. Country Morning Large 2 1/2 Dozen Eggs, UPC 0 79307-00516 2. 19. Country Morning Extra Large 12 Eggs, Net Wt 27 oz (1lb 11oz) 766g, UPC 0 78566-00102 1. 20. Country Morning Jumbo 12 Eggs, Net Wt 30 oz (1lb 14oz) 851g, UPC 0 78566-00101 4. 21. Cal-Maine Sunups 2 1/2 Dozen Eggs, UPC 0 28621-30498 7. Packed by Tx Lic #s. 0840962, 0840961 MPS Egg Farms, 2750 County Road 1011, Center, TX 75935. Bulk Product packaged as follows: 22. Medium Grade A JD 183, 15 dozen, MPS Egg Farms TX Lic. No. 0840961, 14374 E Hwy 21, Byran, TX 77808. 23. Medium Grade A JD 158, 30 dozen, MPS Egg Farms TX Lic. No. 0840961, 14374 E Hwy 21, Byran, TX 77808. 24. Large Grade A JD 193, 15 dozen, MPS Egg Farms TX Lic. No. 0840961, 14374 E Hwy 21, Byran, TX 77808. 25. Large Grade A JD 193, 30 dozen MPS Egg Farms TX Lic. No. 0840961, 14374 E Hwy 21, Byran, TX 77808. 26. Grade A Large Egg JD 208, 900 dozen, Distributed by MPS Egg Farms, 14374 E Hwy 21, Byran, TX 77808. 27. Extra Large Grade A, JD 193, 15 dozen, MPS Egg Farms TX Lic. No. 0840961, 14374 E Hwy 21, Byran, TX 77808. 28. Jumbo Grade A, JD 175, 16.67 Dozen, MPS Egg Farms TX Lic. No. 0840961, 14374 E Hwy 21, Byran, TX 77808. Keep Refrigerated at or Below 45-Degrees F.

Possible Salmonella Enteritidis