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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 661–680 of 1,000 recalls

Class IITerminated

dilTIAZem added to 0.9% sodium chloride, 125 mg/125 mL* (1 mg/mL), 125 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6055-1.

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

April 28, 2023 · DrugView details →
Class IITerminated

PHENYLephrine added to 0.9% sodium chloride, 20 mg/250 mL* (80 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7025-1.

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

April 28, 2023 · DrugView details →
Class IITerminated

Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutaneous Use, Rx Only, Sterile, Distributor: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054, USA, NDC 55566-1010-1

Sun Pharmaceutical Industries Ltd.

Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.

April 19, 2023 · DrugView details →
Class IITerminated

Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0587-90

PD-Rx Pharmaceuticals, Inc.

CGMP deviations.

April 6, 2023 · DrugView details →
Class IITerminated

Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0762-30

PD-Rx Pharmaceuticals, Inc.

CGMP deviations.

April 6, 2023 · DrugView details →
Class IITerminated

Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0727-30) b) 90 count-bottle (NDC 43063-0727-90)

PD-Rx Pharmaceuticals, Inc.

CGMP deviations.

April 6, 2023 · DrugView details →
Class IITerminated

Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottles (NDC 43063-008-30), b) 90 count-bottles (NDC: 43063-0008-90)

PD-Rx Pharmaceuticals, Inc.

CGMP deviations.

April 6, 2023 · DrugView details →
Class IITerminated

Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0726-30) b) 90 count-bottle (NDC 43063-0726-90)

PD-Rx Pharmaceuticals, Inc.

CGMP deviations.

April 6, 2023 · DrugView details →
Class IITerminated

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

Preferred Pharmaceuticals, Inc.

CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.

March 27, 2023 · DrugView details →
Class IITerminated

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.

Preferred Pharmaceuticals, Inc.

CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.

March 27, 2023 · DrugView details →
Class IITerminated

Isopropyl Alcohol Antiseptic 75%, Topical Solution, Hand Sanitizer Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013. NDC: 74663-002-01

Jarman's Midwest Cleaning Systems, Inc.

CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products.

March 27, 2023 · DrugView details →
Class IITerminated

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.

Preferred Pharmaceuticals, Inc.

CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.

March 27, 2023 · DrugView details →
Class IITerminated

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

RemedyRepack Inc.

cGMP Deviations

March 20, 2023 · DrugView details →
Class IITerminated

Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC70518-2750-00

RemedyRepack Inc.

cGMP Deviations

March 20, 2023 · DrugView details →
Class IITerminated

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

RemedyRepack Inc.

cGMP Deviations

March 20, 2023 · DrugView details →
Class IITerminated

Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-00) and b) 90-count bottles (NDC 70518-1946-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.

RemedyRepack Inc.

cGMP Deviations

March 20, 2023 · DrugView details →
Class IITerminated

Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03), b) 90-count bottles (NDC 70518-0405-00) and c)180-count bottles (NDC 70518-0405-02), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701

RemedyRepack Inc.

cGMP Deviations

March 20, 2023 · DrugView details →
Class IITerminated

Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-00

RemedyRepack Inc.

cGMP Deviations

March 20, 2023 · DrugView details →
Class IITerminated

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.

RemedyRepack Inc.

cGMP Deviations

March 20, 2023 · DrugView details →
Class IITerminated

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.

RemedyRepack Inc.

cGMP Deviations

March 20, 2023 · DrugView details →
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