Drug and pharmaceutical recalls

17623 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.

2023-04-12FDA-DrugPreferred Pharmaceuticals, Inc.Class II
Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9429-9
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
2023-04-12FDA-DrugPreferred Pharmaceuticals, Inc.Class II
Simvastatin Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9747-9
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
2023-04-12FDA-DrugPreferred Pharmaceuticals, Inc.Class II
Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8215-9
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
2023-04-12FDA-DrugPreferred Pharmaceuticals, Inc.Class II
Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7971-3
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
2023-04-12FDA-DrugPreferred Pharmaceuticals, Inc.Class II
Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) 30-count bottle (NDC 68788-7086-3); b) 90-count bottle (NDC 68788-7086-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
2023-04-12FDA-DrugPreferred Pharmaceuticals, Inc.Class II
Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3); b) 60-count bottle (NDC 68788-9438-6); c) 90-count bottle (NDC 68788-9438-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
2023-04-12FDA-DrugPreferred Pharmaceuticals, Inc.Class II
Glimepiride Tablets, USP, 2 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8095-9
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
2023-04-12FDA-DrugPreferred Pharmaceuticals, Inc.Class II
Finasteride Tablets, USP, 5 mg, packaged in: a) 30-count bottles (NDC 68788-6976-3); b) 90-count bottles (NDC 68788-6976-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
2023-04-12FDA-DrugPreferred Pharmaceuticals, Inc.Class II
Doxazosin Tablets, USP, 4 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7149-1
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
2023-04-12FDA-DrugPreferred Pharmaceuticals, Inc.Class II
Doxazosin Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7328-1
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
2023-04-12FDA-DrugPreferred Pharmaceuticals, Inc.Class II
Clopidogrel Tablets USP, 75 mg, 90-count bottles, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8190-9
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
2023-04-12FDA-DrugPreferred Pharmaceuticals, Inc.Class II
Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (NDC 68788-7631-9); b) 30-count bottle (NDC 68788-7631-3), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
2023-04-12FDA-DrugPreferred Pharmaceuticals, Inc.Class II
Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7630-9
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
2023-04-12FDA-DrugTeva Pharmaceuticals USA IncClass III
Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Carton NDC 0093-7487-56, Packet NDC 0093-7487-19
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
2023-04-12FDA-DrugDirect RxClass II
Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-121-60.
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
2023-04-12FDA-DrugDirect RxClass II
Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534.
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
2023-04-12FDA-DrugDirect RxClass II
Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0240-30.
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
2023-04-12FDA-DrugPreferred Pharmaceuticals, Inc.Class II
Alprazolam Tab, USP 1mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7596-3), b) 60-count bottle (NDC68788-7596-6); Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL.
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
2023-04-12FDA-DrugPreferred Pharmaceuticals, Inc.Class II
Alprazolam Tab, USP 0.5mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7595-3), b) 60-count bottle (NDC 68788-7595-6), c) 90-count bottle (NDC 68788-7595-9); Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL.
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
2023-04-12FDA-DrugPreferred Pharmaceuticals, Inc.Class II
Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL. Ins:NDC 68788-7594-3
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
2023-04-12FDA-DrugRemedyRepack Inc.Class II
Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 90-count bottles (NDC 70518-0060-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
cGMP Deviations
2023-04-12FDA-DrugRemedyRepack Inc.Class II
Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b) 90-count bottles (NDC 70518-0484-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
cGMP Deviations
2023-04-12FDA-DrugRemedyRepack Inc.Class II
Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 and 70518-0375-01) and b) 90-count bottles (NDC 70518-0375-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
cGMP Deviations
2023-04-12FDA-DrugRemedyRepack Inc.Class II
Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00
cGMP Deviations
2023-04-12FDA-DrugRemedyRepack Inc.Class II
Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC70518-2750-00
cGMP Deviations
2023-04-12FDA-DrugRemedyRepack Inc.Class II
Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-00) and b)90-count bottles (NDC 70518-1977-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
cGMP Deviations
2023-04-12FDA-DrugRemedyRepack Inc.Class II
Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-00
cGMP Deviations
2023-04-12FDA-DrugRemedyRepack Inc.Class II
Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01) and b) 90-count bottles (NDC 70518-0064-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
cGMP Deviations
2023-04-12FDA-DrugRemedyRepack Inc.Class II
Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00.
cGMP Deviations
2023-04-12FDA-DrugRemedyRepack Inc.Class II
Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2439-00.
cGMP Deviations

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