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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 81–100 of 1,000 recalls

Class IITerminated

Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24

BLI International, Inc.

Superpotent Drug: Stability failure for assay at 6 months test time-point.

October 21, 2024 · DrugView details →

Class IITerminated

Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Accord Healthcare Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad 382 213, India. Mfg. Lic. No.: G/28/1336, NDC 16729-288-38

ACCORD HEALTHCARE, INC.

Failed Impurities/Degradation Specifications.

October 1, 2024 · DrugView details →

Class IITerminated

NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-027-58

Fresenius Kabi Compounding, LLC

cGMP violations

September 25, 2024 · DrugView details →

Class IITerminated

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58

Fresenius Kabi Compounding, LLC

cGMP violations

September 25, 2024 · DrugView details →

Class IITerminated

EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58

Fresenius Kabi Compounding, LLC

cGMP violations

September 25, 2024 · DrugView details →

Class IITerminated

Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59

Fresenius Kabi Compounding, LLC

cGMP violations

September 25, 2024 · DrugView details →

Class IITerminated

NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58

Fresenius Kabi Compounding, LLC

cGMP violations

September 25, 2024 · DrugView details →

Class IITerminated

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-024-58

Fresenius Kabi Compounding, LLC

cGMP violations

September 25, 2024 · DrugView details →

Class IITerminated

Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-079-56

Fresenius Kabi Compounding, LLC

cGMP violations

September 25, 2024 · DrugView details →

Class IITerminated

Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58

Fresenius Kabi Compounding, LLC

cGMP violations

September 25, 2024 · DrugView details →

Class IITerminated

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58

Fresenius Kabi Compounding, LLC

CGMP violations

September 25, 2024 · DrugView details →

Class IITerminated

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58

Fresenius Kabi Compounding, LLC

cGMP violations

September 25, 2024 · DrugView details →

Class IITerminated

Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Umedica Laboratories Pvt Ltd., Vapi Gujarat 396195, India, NDC: 75834-257-01.

Nivagen Pharmaceuticals Inc

Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.

September 24, 2024 · DrugView details →

Class IITerminated

Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and marketed by Halozyme, Inc., 12390 El Camino Real San Diego California 92130, Distributed by Antares Pharma, Inc., Ewing, NJ NDC 18657-117-04

Mckesson Medical-Surgical Inc. Corporate Office

cGMP Deviations: Temperature excursion

September 11, 2024 · DrugView details →

Class IITerminated

Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208-730-06

Mckesson Medical-Surgical Inc. Corporate Office

Temperature abuse: Products exposed to improper temperature above drug label specifications.

September 11, 2024 · DrugView details →

Class IITerminated

Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX Only, Compounded by: Empower Pharmacy 5980 W Sam Houston Pkwy N Ste 300, Houston, TX 77041 NDC 72627-2424-1.

Empower Pharmacy

Lack of Assurance of Sterility

September 5, 2024 · DrugView details →

Class IITerminated

Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01

Lupin Pharmaceuticals Inc.

Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.

August 21, 2024 · DrugView details →

Class IITerminated

Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial, For IM or SQ use only, RX only, Compounded by: Empower Pharmacy 7601 N Sam Houston Pkwy W Ste 100, Houston, TX 77064

EMPOWER CLINIC SERVICES LLC

Lack of Assurance of Sterility

August 2, 2024 · DrugView details →

Class IITerminated

Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA NDC 70010-227-05

Granules Pharmaceuticals Inc.

Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets

July 31, 2024 · DrugView details →

Class IITerminated

Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun - 248-197, Uttarakhand, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-233-88.

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Dissolution Specifications

July 9, 2024 · DrugView details →

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