FDA recalls, April 2019: 143 published

63 different companies appear this month.

Risk classification: Class I: 13 · Class II: 118 · Class III: 12

Same month, other agencies:CPSC 27 recallsFSIS 7 recallsNHTSA 87 recalls

Recalls this month

DateProduct
April 24, 2019Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-05…D-1133-2019Dr. Reddy's Laboratories, Inc.
April 24, 2019HCG 11,000 Units, 30 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, …D-1147-2019Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
April 24, 2019Prostaglandin Quad with Atropine 10:30:1:0.15, 2 mL Vial, Anderson Compounding Pharmacy 3…D-1172-2019Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
April 24, 2019Heparin 10 mL/Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/per 70 mL, Anderson Compo…D-1159-2019Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
April 24, 2019FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-AS…Z-1133-2019BioFire Diagnostics, LLC
April 24, 2019Remifentanil HCl active pharmaceutical ingredient (API) for manufacturing, processing or …D-1252-2019Johnson Matthey Inc.
April 24, 2019Vitamin D3 200,000 IU/mL Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff Ci…D-1182-2019Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
April 24, 2019NadaMoo! Strawberry Cheesecake Non-Dairy Frozen-Dessert 16 ounce/pint packaged in a cartonF-1288-2019LITTLE RED ROOSTER COMPANY
April 24, 2019Bacitracin 3000U/30 mL Irrigation, 30 mL Syringe, Anderson Compounding Pharmacy 310 Bluff…D-1180-2019Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
April 24, 2019Addback Tablet Dietary Supplement 60 tablets per 190cc Oblong WHDPE bottle Net Wet: …F-1295-2019Cays LLC
April 24, 2019Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Right, Part No. LJU…Z-1152-2019Integra LifeSciences Corp.
April 24, 2019Serum Tears 50% Ophthalmic Drops, 1 mL Dropper, Anderson Compounding Pharmacy 310 Bluff C…D-1184-2019Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
April 24, 2019Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Left, Part No. LJU2…Z-1154-2019Integra LifeSciences Corp.
April 24, 2019Prostaglandin 40 mcg/mL, Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol,…D-1169-2019Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
April 24, 2019Breads from Anna Banana Bread Mix 14oz, cartonF-1291-2019Wholesome Treats, Inc.
April 24, 2019HCG 23 Day Injection Extra Strength, vials, Anderson Compounding Pharmacy 310 Bluff City …D-1153-2019Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
April 24, 2019HCG 4,100 Units/vial Injection, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol…D-1154-2019Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
April 24, 2019Prostaglandin Tri-Mix 20:30:1, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City H…D-1173-2019Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
April 24, 2019Heparin 2 mL/Lidocaine 2%-10 mL/Sodium Bicarbonate 8.4%-5mL/ Sterile Water 10 mL, Anderso…D-1160-2019Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
April 24, 2019Estrone 5mg/mL Oil Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hw…D-1195-2019Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
April 24, 2019Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XSZ-1184-2019Gyrus ACMI, Inc.
April 24, 2019Heparin 20,000 U/Lidocaine 2% 10 mL/Sodium Bicarbonate 8.4% 10 mL/Sterile Water 5 mL, 27 …D-1156-2019Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
April 24, 2019icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b) REF CL-…Z-1097-2019ICU Medical, Inc.
April 24, 2019Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No. LJU813TZ-1167-2019Integra LifeSciences Corp.
April 24, 2019Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufa…D-1136-2019Iso-Tex Diagnostics, Inc
April 24, 2019Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC …D-1205-2019Teva Pharmaceuticals USA
April 24, 2019Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding cathete…Z-1198-2019Cordis Corporation
April 24, 2019Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Left, Product No. LJV191TZ-1173-2019Integra LifeSciences Corp.
April 24, 2019Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trau…Z-1082-2019Brainlab AG
April 24, 2019Breads from Anna Classic Herb Bread Mix 19oz, cartonF-1294-2019Wholesome Treats, Inc.
April 24, 2019Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/1…Z-1146-2019Roche Diagnostics Corporation
April 24, 2019A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad. PPWS-001 …Z-1139-2019Pintler Medical LLC
April 24, 2019Edamame Salad sold under the following labels: BOSTON SALADS Prepared Foods EDAMAME SALAD…F-1289-2019Boston Salads & Provisions Co., Inc.
April 24, 2019Gentamicin 160 mg/1000 mL Sterile Water for Irrigation,1000 mL Bottle, Anderson Compoundi…D-1192-2019Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
April 24, 2019DMSO 50% 60 mL/Heparin 1 mL/ Sodium Bicarbonate 60 mL/ Solu-Cortef 100 mg, 41 mL syringe,…D-1142-2019Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
April 24, 2019HCG 20 Day Injection, 2625 Units/4 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, …D-1148-2019Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
April 24, 2019Serum Tears 20% Drops, 1 mL Droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy,…D-1177-2019Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
April 24, 2019Prostaglandin Tri-Mix 20:25:1 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Blu…D-1203-2019Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
April 24, 201914F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422Z-1149-2019Medical Components, Inc dba MedComp
April 24, 2019Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB200…Z-1179-2019Gyrus ACMI, Inc.
April 24, 2019Acetylcysteine 10% Ophthalmic Eye Drop 2 mL droptainer, Anderson Compounding Pharmacy 310…D-1137-2019Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
April 24, 2019Morphine Sulfate 5 mg/3mL Inhalation, 3 mL Vials, Anderson Compounding Pharmacy 310 Bluff…D-1164-2019Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
April 24, 2019Methylcobalamin 3000 mcg/mL Injection Solution, 2 mL Vial, Anderson Compounding Pharmacy …D-1183-2019Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
April 24, 2019Prostaglandin Tri-Mix 2.5:7.5:0.25 Injection, 2 mL Vial, Anderson Compounding Pharmacy 31…D-1201-2019Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
April 24, 2019Heparin 10 mL/ Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/ Normal Saline 5 mL, 60 …D-1157-2019Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
April 24, 2019Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XCZ-1185-2019Gyrus ACMI, Inc.
April 24, 2019Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By: F…D-1206-2019Brian P. Richardson
April 24, 2019Dexamethasone 24 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy, 310 Bluff C…D-1141-2019Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
April 24, 2019HCG 23 Day, 2876 Units/4.6 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bri…D-1149-2019Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
April 24, 2019Heparin 10 mL/Marcaine 0.25% 20 mL/Sodium Bicarbonate 40 mL/Normal Saline 5 mL per 75 mL,…D-1194-2019Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

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