All Recalls

95,114 total recalls in our database

Savannah Food Company

🍎 Food Class I - Dangerous

Eggs used in the manufacture of the products may be contaminated with listeria monocytogenes

Dec 30, 2019 Bakery & Bread View Details →

Smoked Salmon Chowder, Pike Place Chowder brand, item #89201, distributed By PPC Trading Co. M. BOX #262 4580 Klahanie Drive SE Issaquah WA 98029. There are 16/16 oz. retail packages per master case. Retail package net wt. 16 oz. UPC 8 56112 00406 7. The 16 oz. inner individual pouch has a clear film lid and the label is read in parts: "Pike Place CHOWDER SMOKED SALMON CHOWDER * CONTAINS: FISH (SALMON), MILK, SHELLFISH (LOBSTER, SHRIMP), WHEAT". The outer RETAIL package, which house the 16 oz. inner individual pouch, is read in parts: "Pike Place CHOWDER * SMOKED SALMON CHOWDER * Wild Northwest Smoked Salmon. Cream Cheese. Capers & Vegetables Keep Frozen. Thaw. Heat & Serve Allergens: Fish, Shellfish, MilkGLUTEN FREE". The MASTER case label is read in parts: "* PIKE PLACE SMOKED SALMON CHOWDER 89201 KEEP FROZEN UNTIL USED. THAW UNDER REFRIGERATION IMMEDIATELY BEFORE USE* PRODUCT MAY BE KEPT UNDER REFRIGERATION FOR UP TO 15 DAYS PRIOR TO USE * CONTAINS: FISH (SALMON), MILK, SHELLFISH (LOBSTER, SHRIMP), WHEAT***".

Northwest Gourmet Food Products

🍎 Food Class I - Dangerous

The outer retail packaging claims "Gluten Free" but the inner individual pouch declares wheat.

Dec 18, 2019 Dairy & Eggs View Details →

Belle Mar Stuffing 5 lb. (2.27 kg) Bulk Plastic Container,6 - 5 lb. containers per case , Keep Frozen

ASK Foods

🍎 Food Class I - Dangerous

The cheese ingredient used in the product tested positive for Listeria monocytogenes.

Dec 2, 2019 Other Foods View Details →

Sea Mart Frozen Yellowfin Tuna Steak, CO treated, skinless, boneless, bloodline removed, 8 oz, 10lb package

AQUABEST SEAFOOD

🍎 Food Class I - Dangerous

Product recalled due to potentially elevated levels of Histamines. Product supplier, TPX, is recalling product which is related to a recent scombrotoxin poisoning outbreak in US.

Nov 26, 2019 Seafood View Details →

Savannah Classics Special Cornbread Dressing packaged in 7lb trays

Savannah Food Company

🍎 Food Class I - Dangerous

Eggs used in the manufacture of the products may be contaminated with listeria monocytogenes

Dec 30, 2019 Bakery & Bread View Details →

New England Clam Chowder, Pike Place Chowder brand, item #89200, distributed By PPC Trading Co. M. BOX #262 4580 Klahanie Drive SE Issaquah WA 98029. There are 12/16 oz. retail packages per master case. Retail package net wt. 16 oz. UPC 8 56112 00402 9. The 16 oz. inner individual pouch has a clear film lid and the label is read in parts: "Pike Place CHOWDER NEW ENGLAND CLAM CHOWDER * CONTAINS: FISH (COD), MILK, SOY, WHEAT". The outer RETAIL package, which house the 16 oz. inner individual pouch, is read in parts: "Pike Place CHOWDER * NEW ENGLAND CLAM CHOWDER * Highest Quality Clams. Farm Fresh Ingredients. Pure Cream & Butter THAWING INSTRUCTIONSCOOKING INSTRUCTIONS Allergens: Fish, Shellfish, Milk, SoyGLUTEN FREE". The MASTER case label is read in parts: " PIKE PLACE CHOWDER * NEW ENGLAND CLAM CHOWDER 89200 KEEP FROZEN UNTIL USED. THAW UNDER REFRIGERATION IMMEDIATELY BEFORE USE* PRODUCT MAY BE KEPT UNDER REFRIGERATION FOR UP TO 15 DAYS PRIOR TO USE * CONTAINS: FISH (COD), MILK, SOY, WHEAT***".

Northwest Gourmet Food Products

🍎 Food Class I - Dangerous

The outer retail packaging claims "Gluten Free" but the inner individual pouch declares wheat.

Dec 18, 2019 Dairy & Eggs View Details →

Sea Mart Frozen Yellowfin Tuna Saku, CO treated, skinless, boneless, bloodline removed, 10-12oz, 10 lb package

AQUABEST SEAFOOD

🍎 Food Class I - Dangerous

Product recalled due to potentially elevated levels of Histamines. Product supplier, TPX, is recalling product which is related to a recent scombrotoxin poisoning outbreak in US.

Nov 26, 2019 Seafood View Details →

Entropic Labs SARM RAD-140, 20mg Capsules, 30-count bottles, Entropic Labs UPC#: 651074545302

Tuscano and Delucia Group (DBA Entropic Labs)

💊 Drugs Class I - Dangerous

Marketed Without An Approved NDA/ANDA: product contains Selective Androgen Receptor Modulators (SARMs)

Aug 24, 2019 Prescription Drugs Nationwide View Details →

Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.

Mylan Pharmaceuticals

💊 Drugs Class I - Dangerous

CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.

Jan 7, 2020 Prescription Drugs View Details →

Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC 70934-017-24) d). 30-count bottle (NDC 70934-017-30) e). 90-count bottle (NDC 70934-017-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131.

Denton Pharma

💊 Drugs Class I - Dangerous

CGMP Deviations: Presence of NDMA impurity detected in product.

Dec 20, 2019 Prescription Drugs Nationwide View Details →

Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e) 60 count; Rx, Only, H.J. Harkins Company, Inc. dba Pharma Pac Grover Beach, CA 93433 NDC #s: 52959-0502-07, 52959-0502-14, 52959-0502-20, 52959-0502-30 and 52959-0502-60

H J Harkins Company Inc

💊 Drugs Class I - Dangerous

CGMP Deviations: Presence of NDMA impurity detected in product.

Jan 6, 2020 Prescription Drugs View Details →

methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), SA; Dist by: WEST-WARD, Eatontown, NJ 07724, NDC 0143-9850-01.

Hikma Pharmaceuticals USA

💊 Drugs Class I - Dangerous

Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol.

Jan 14, 2020 Prescription Drugs Nationwide View Details →

Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.

Mylan Pharmaceuticals

💊 Drugs Class I - Dangerous

CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.

Jan 7, 2020 Prescription Drugs View Details →

Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00

RemedyRepack

💊 Drugs Class I - Dangerous

CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.

Dec 11, 2019 Prescription Drugs View Details →

NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, Rx Only, Manufactured for: Advanced Accelerator Applications USA, Inc. by Gipharma S.r.l. Strada Crescentino snc, 13040 Saluggia (Vc), Italy, NDC 69488-001-40.

Advanced Accelerator Applications USA

💊 Drugs Class I - Dangerous

Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).

Jan 10, 2020 Prescription Drugs Nationwide View Details →

Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131

Denton Pharma

💊 Drugs Class I - Dangerous

CGMP Deviations: Presence of NDMA impurity detected in product.

Dec 20, 2019 Prescription Drugs Nationwide View Details →

Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only, a) 14 count bottles (NDC: 68788-6382-1), b) 30 count bottles (NDC: 68788-6382-3), c) 90 count bottles (NDC: 68788-6382-9), d) 100 count bottles (NDC: 68788-6382-0)

Preferred Pharmaceuticals

💊 Drugs Class I - Dangerous

CGMP Deviations: Presence of NDMA impurity detected in product.

Jan 7, 2020 Prescription Drugs View Details →

Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, a) 30 count bottles (NDC: 68788-7388-3), b) 60 count bottles (NDC: 68788-7388-6), c) 90 count bottles (NDC: 68788-7388-9), d) 100 count bottles (NDC: 68788-7388-1)

Preferred Pharmaceuticals

💊 Drugs Class I - Dangerous

CGMP Deviations: Presence of NDMA impurity detected in product.

Jan 7, 2020 Prescription Drugs View Details →

Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images.

Koios Medical

🏥 Medical Devices Class I - Dangerous

Affected software product versions were found during internal audit to have been marketed for sale without sufficient documentation pertaining to certain required quality procedures.

Dec 31, 2019 Other Medical Devices View Details →

PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700

Polymer Technology Systems

🏥 Medical Devices Class I - Dangerous

One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheating.

Dec 2, 2019 Diagnostic Equipment Nationwide View Details →