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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 6781–6800 of 17,773 recalls

Class IITerminated

L-Carnitine 27 mL in a 30 mL Vial, 4,590 mg/27 mL (170 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674166

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

September 12, 2019 · DrugView details →

Class IITerminated

ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 25 mg/5 mL (5 mg/mL) 5 mL Fill in a 6 mL Syringe, Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678374

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

September 12, 2019 · DrugView details →

Class IITerminated

LIDOcaine HCl 1% (PF) 50 mg/5 mL (10 mg/mL), 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678424

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

September 12, 2019 · DrugView details →

Class IITerminated

NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678406

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

September 12, 2019 · DrugView details →

Class IITerminated

Methylcobalamin 30 mL Vial-For SC / IM / IV Use, 30 mg / 30 mL (1 mg / mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674232

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

September 12, 2019 · DrugView details →

Class IITerminated

Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL) / Ketorolac Tromethamine 0.5% (2.5 mg/0.5 mL), Sterile Ophthalmic Topical Solution, 0.5 mL Fill in 3 mL Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677510

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

September 12, 2019 · DrugView details →

Class IITerminated

Human Chorionic Gonadotropin 5,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC03321673964

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

September 12, 2019 · DrugView details →

Class IITerminated

SUCCinylcholine Chloride (PF), 200 mg/10 mL (20 mg/mL), 10 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678416

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

September 12, 2019 · DrugView details →

Class IITerminated

Norepinephrine added to 5% Dextrose (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678217

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

September 12, 2019 · DrugView details →

Class IITerminated

LIDOcaine HCl 2% (PF) 100 mg/5 mL (20 mg/mL) 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487NDC 3321678315

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

September 12, 2019 · DrugView details →

Class IITerminated

Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL per bottle, Rx Only, Distr. by: West-Ward Pharmaceuticals,Eatontown, NJ. NDC:0054-0199-59

West-Ward Columbus Inc

Failed Impurities/Degradation Specificattion

September 9, 2019 · DrugView details →

Class IIITerminated

Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. Made in India. NDC: 0378-5431-35

Mylan Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications:OOS for unknown impurity.

September 6, 2019 · DrugView details →

Class IITerminated

Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hospira, Inc., Lake Forest, IL 60045 USA. NDC Vial: 0409-3977-01; NDC Carton: 0409-3977-03

Pfizer Inc.

Lack of Assurance of Sterility

September 6, 2019 · DrugView details →

Class IIITerminated

Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30 count bottle, Rx only, Manufactured by: Actabis Laboratories FL, Inc., Fort Lauderdale, FL, Distributed by: Actavis Pharma, Inc., Parsippany, NJ NDC 52544-692-30

Teva Pharmaceuticals USA

GMP Deviation: lot not intended for commercial distribution.

September 6, 2019 · DrugView details →

Class IITerminated

Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-453-01.

Torrent Pharma Inc.

Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.

September 6, 2019 · DrugView details →

Class ITerminated

Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g NDC# 71052-530-05; b) 50 g NDC# 71052-530-55, c) 25g NDC# 71052-530-25, Darmerica LLC 198 Wilshire Blvd Casselberry, FL 32707

Darmerica, LLC

Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin.

September 6, 2019 · DrugView details →

Class IITerminated

Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For subcutaneous use only, Rx Only, Manufactured by GlaxoSmithKline LLC, Philadelphia, PA 19112, Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0892-42.

Cardinal Health dba Specialty Pharmaceutical Services

Temperature Abuse; Product stored and shipped outside of labeled storage requirements.

September 6, 2019 · DrugView details →

Class IITerminated

Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd, Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-284-90

Jubilant Cadista Pharmaceuticals, Inc.

CGMP Deviation: Presence of dark brown discoloration on edges of tablets.

September 4, 2019 · DrugView details →

Class IITerminated

Hydromorphone HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

Coast Quality Pharmacy, LLC dba Anazao Health

Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.

September 3, 2019 · DrugView details →

Class IITerminated

Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

Coast Quality Pharmacy, LLC dba Anazao Health

Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.

September 3, 2019 · DrugView details →

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