FoodMay 1, 2019
Winter Gardens Quality Foods Chips & Chocolate, A layered dessert with chocolate mousse recall — FDA F-1325-2019
Products potentially contaminated with Salmonella.
Class IFDA: TerminatedWinter Gardens Quality Foods, Inc.
May 2019 recalls — page 17
These records include useful source details for the selected month.
FoodMay 1, 2019
The CF Sauer Company MONARCH SOUTHERN BARBECUE SAUCE MADE WITH MUSTARD NET 128 FL recall — FDA F-1303-2019
Monarch Southern BBQ contains soy and wheat. The firm had labels that properly described the product as Monarch Southern BBQ, but did not have the correct UPC, nutrition panel, ingredient…
Class IFDA: CompletedThe CF Sauer Company
FoodMay 1, 2019
Patagonia Provisions Savory Seeds Pack recall — FDA F-1299-2019
Products are labeled gluten free but have been found to contain gluten in excess of 20 ppm in finished products.
Class IIFDA: TerminatedPatagonia Provisions Inc.
FoodMay 1, 2019
Patagonia Provisions Classic Barbecue Savory Seeds recall — FDA F-1296-2019
Products are labeled gluten free but have been found to contain gluten in excess of 20 ppm in finished products.
Class IIFDA: TerminatedPatagonia Provisions Inc.
DrugMay 1, 2019
Akorn Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton recall — FDA D-1241-2019
Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing.
Class IIIFDA: TerminatedAkorn Inc.
DrugMay 1, 2019
Carvedilol Tablets, USP, 3.125 mg, 500-count bottle recall — FDA D-1242-2019
Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a…
Class IIIFDA: TerminatedZydus Pharmaceuticals USA Inc.
DrugMay 1, 2019
Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottles recall — FDA D-1244-2019
Failed Impurities/Degradation Specifications
Class IIIFDA: TerminatedLUPIN SOMERSET
DrugMay 1, 2019
Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles recall — FDA D-1243-2019
Failed Impurities/Degradation Specifications
Class IIIFDA: TerminatedLUPIN SOMERSET
DrugMay 1, 2019
Morphine Sulfate Extended-Release Tablets, 200 mg recall — FDA D-1247-2019
Failed Impurities/Degradation Specifications
Class IIIFDA: TerminatedLUPIN SOMERSET
DrugMay 1, 2019
CMC Enterprise Pharmacy DelNido Cardioplegia recall — FDA D-1240-2019
Lack of sterility assurance.
Class IIFDA: TerminatedCMC Enterprise Pharmacy
DrugMay 1, 2019
Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles recall — FDA D-1246-2019
Failed Impurities/Degradation Specifications
Class IIIFDA: TerminatedLUPIN SOMERSET
DrugMay 1, 2019
Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles recall — FDA D-1245-2019
Failed Impurities/Degradation Specifications
Class IIIFDA: TerminatedLUPIN SOMERSET
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.