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FDA Recalls
›Drug Recalls

FDA Drug Recalls

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

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 661–680 of 1,000 recalls

Class IITerminated

tromethamine 0.3 Molar, 50 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8086-2.

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

oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6042-1.

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

Cardioplegia Solution, Modified St Thomas Solution, low potassium, HIGH SODIUM BICARBONATE, 62 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0203-1.

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

Cardioplegia Solution, del Nido Formula, packaged in 1,052.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0202-1.

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

Neonatal PN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100 Allentown, PA 18106, NDC 71285-0429-1.

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

Cardioplegia Solution, LEESBURG CARDIOPLEGIA, packaged in 1030.2 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0218-1.

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

oxyTOCIN 60 units added to 0.9% sodium chloride 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6045-1.

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

heparin added to 0.9% sodium chloride, 7,500 units/1,000 mL* (7.5 units/mL), 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7009-1.

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

Modified del Nido Microplegia, packaged in 40 mL per syringe, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0219-1.

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

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 →

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