DrugJun 14, 2017
Qualgen Estradiol 6 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count recall — FDA D-0896-2017
CGMP deviations- Lack of Quality Assurance
Class IIFDA: TerminatedQualgen
June 2017 recalls — page 4
These records include useful source details for the selected month.
DrugJun 14, 2017
Acyclovir Tablets, USP, 800 mg, 100-count bottle recall — FDA D-0897-2017
Presence of Foreign Substance: human hair melded into tablet.
Class IIIFDA: TerminatedHetero USA Inc.
DrugJun 14, 2017
Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count recall — FDA D-0883-2017
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Class IIFDA: TerminatedDr. Reddy's Laboratories, Inc.
DrugJun 14, 2017
Qualgen Estradiol 25 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 recall — FDA D-0889-2017
CGMP deviations- Lack of Quality Assurance
Class IIFDA: TerminatedQualgen
DrugJun 14, 2017
Qualgen Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 recall — FDA D-0892-2017
CGMP deviations- Lack of Quality Assurance
Class IIFDA: TerminatedQualgen
DrugJun 14, 2017
Qualgen Estradiol 22 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 recall — FDA D-0890-2017
CGMP deviations- Lack of Quality Assurance
Class IIFDA: TerminatedQualgen
DrugJun 14, 2017
Spectrum Laboratory Products Estradiol recall — FDA D-0881-2017
CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current…
Class IIFDA: TerminatedSpectrum Laboratory Products, Inc.
DrugJun 14, 2017
Qualgen Estradiol 10 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 recall — FDA D-0895-2017
CGMP deviations- Lack of Quality Assurance
Class IIFDA: TerminatedQualgen
DrugJun 14, 2017
Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count recall — FDA D-0884-2017
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Class IIFDA: TerminatedDr. Reddy's Laboratories, Inc.
DrugJun 14, 2017
Qualgen Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 recall — FDA D-0894-2017
CGMP deviations- Lack of Quality Assurance
Class IIFDA: TerminatedQualgen
DrugJun 14, 2017
Qualgen Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 recall — FDA D-0891-2017
CGMP deviations- Lack of Quality Assurance
Class IIFDA: TerminatedQualgen
FoodJun 7, 2017
The Smokehouse of New York, LLC Refrigerated, ready-to-eat, hot SMOKED STURGEON, HAND SLICED recall — FDA F-2261-2017
The products have the potential to be contaminated with Listeria monocytogenes based on FDA sampling and analysis. During an FDA inspection, an environmental sample (973983) was collected…
Class IFDA: TerminatedThe Smokehouse of New York, LLC.
FoodJun 7, 2017
Tyson Foods Sara Lee CP Quiche 10 Spinach , 38 oz recall — FDA F-2248-2017
The firm is voluntarily recalling multiple lots of frozen Chef Pierre 10 Spinach Quiche, Chef Pierre 6/10 Frozen Quiche, and Sara Lee CP Quiche 10 Spinach following an ingredient supplier's…
Class IIFDA: TerminatedTyson Foods, Inc.
FoodJun 7, 2017
The Smokehouse of New York, LLC Refrigerated, ready-to-eat, sliced, hot SMOKED TROUT fillets recall — FDA F-2260-2017
The products have the potential to be contaminated with Listeria monocytogenes based on FDA sampling and analysis. During an FDA inspection, an environmental sample (973983) was collected…
Class IFDA: TerminatedThe Smokehouse of New York, LLC.
FoodJun 7, 2017
Tyson Foods Chef Pierre 10 Spinach Quiche, and 6/10 Frozen Quiche, 38 oz recall — FDA F-2247-2017
The firm is voluntarily recalling multiple lots of frozen Chef Pierre 10 Spinach Quiche, Chef Pierre 6/10 Frozen Quiche, and Sara Lee CP Quiche 10 Spinach following an ingredient supplier's…
Class IIFDA: TerminatedTyson Foods, Inc.
FoodJun 7, 2017
The Smokehouse of New York, LLC Refrigerated, ready-to-eat, sliced, cold smoked, GRAVLAX recall — FDA F-2258-2017
The products have the potential to be contaminated with Listeria monocytogenes based on FDA sampling and analysis. During an FDA inspection, an environmental sample (973983) was collected…
Class IFDA: TerminatedThe Smokehouse of New York, LLC.
FoodJun 7, 2017
The Smokehouse of New York, LLC Refrigerated, ready-to-eat, sliced, whole, split, hot SMOKED recall — FDA F-2262-2017
The products have the potential to be contaminated with Listeria monocytogenes based on FDA sampling and analysis. During an FDA inspection, an environmental sample (973983) was collected…
Class IFDA: TerminatedThe Smokehouse of New York, LLC.
FoodJun 7, 2017
The Smokehouse of New York, LLC Refrigerated, ready-to-eat, sliced, cold smoked, SMOKED recall — FDA F-2254-2017
The products have the potential to be contaminated with Listeria monocytogenes based on FDA sampling and analysis. During an FDA inspection, an environmental sample (973983) was collected…
Class IFDA: TerminatedThe Smokehouse of New York, LLC.
FoodJun 7, 2017
The Smokehouse of New York, LLC Refrigerated, ready-to-eat, sliced, hot SMOKED SABLE, BLACK recall — FDA F-2263-2017
The products have the potential to be contaminated with Listeria monocytogenes based on FDA sampling and analysis. During an FDA inspection, an environmental sample (973983) was collected…
Class IFDA: TerminatedThe Smokehouse of New York, LLC.
FoodJun 7, 2017
Trident Seafoods Corp - Island Enterprise M/V Multi-Grain Alaskan Cod, Frozen, RETAIL recall — FDA F-2277-2017
Multi-Grain Alaskan Cod, Frozen product, retail 12 oz. packages are recalled because they may contain small pieces of plastic.
Class IIFDA: TerminatedTrident Seafoods Corp - Island Enterprise M/V
FoodJun 7, 2017
MusclMasster The Green Herb 100% Natural AL-ER-G, 60 and 150 Capsules recall — FDA F-2291-2017
MusclMasster, LLC is recalling all bottles of Al-Er-G Capsules because they contain the presence of Ephedra Herb, an FDA banned ingredient.
Class IFDA: TerminatedMusclMasster, LLC
FoodJun 7, 2017
The Smokehouse of New York, LLC Refrigerated, ready-to-eat, sliced, cold smoked, IMPORTED recall — FDA F-2256-2017
The products have the potential to be contaminated with Listeria monocytogenes based on FDA sampling and analysis. During an FDA inspection, an environmental sample (973983) was collected…
Class IFDA: TerminatedThe Smokehouse of New York, LLC.
FoodJun 7, 2017
Trident Seafoods Corp - Island Enterprise M/V Irregulars Breaded Cod 2 oz recall — FDA F-2284-2017
Irregulars Breaded Cod 2 oz. 10 Grain Cod product is recalled because it may contain small pieces of plastic.
Class IIFDA: TerminatedTrident Seafoods Corp - Island Enterprise M/V
FoodJun 7, 2017
The Smokehouse of New York, LLC Refrigerated, ready-to-eat, sliced, hot SMOKED WHITEFISH recall — FDA F-2265-2017
The products have the potential to be contaminated with Listeria monocytogenes based on FDA sampling and analysis. During an FDA inspection, an environmental sample (973983) was collected…
Class IFDA: TerminatedThe Smokehouse of New York, LLC.
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.