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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 3721–3740 of 17,755 recalls

Class IIITerminated

Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution 3mL vial, packaged in a) 30-count (NDC 0487-0201-03), b) 60-count (NDC 0487-0201-60), Rx only, MFG: Nephron Pharma

Mckesson Medical-Surgical Inc. Corporate Office

cGMP deviations: Temperature abuse

April 13, 2022 · DrugView details →

Class IIITerminated

Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneous Use Only, 25 x 1 mL Vials, Rx only, Manufactured by: Eugia Pharma Specialties Limited, Hyderabad India for BluePoint Laboratories. NDC for Carton: 68001-509-60; NDC for vial: 68001-509-59

American Health Packaging

Subpotent Drug: Out of specification for assay.

April 12, 2022 · DrugView details →

Class ITerminated

Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL Multiple-Dose vial inside a carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Manufactured for: Mylan Specialty L.P., Morgantown, WV 26505, NDC 49502-393-80

Mylan Pharmaceuticals Inc

Labeling: Missing label on the vial

April 12, 2022 · DrugView details →

Class IITerminated

Losartan Potassium Tab. USP 50mg, Pkg Size: 30, Mfg: Lupin Pharmaceuticals, Inc., Preferred Pharmaceuticals, Inc.

Preferred Pharmaceuticals, Inc.

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.

April 12, 2022 · DrugView details →

Class IITerminated

Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent Pharmaceuticals Ltd., Indrad-382 721, India, Manufactured for: Torrent Pharma Inc., Levittown, PA 19057, NDC# 13668-096-90.

Torrent Pharma Inc

CGMP deviations: tablets cracking

April 11, 2022 · DrugView details →

Class IITerminated

Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., NDC 67457-445-60

Mylan Pharmaceuticals Inc

Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.

April 7, 2022 · DrugView details →

Class IITerminated

Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1), b) 60-count blister card (NDC: 70518-3282-0), Rx Only, MFG by: Lupin Pharma, Baltimore, MD 21202.

RemedyRepack Inc.

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.

April 6, 2022 · DrugView details →

Class IITerminated

Kill 'Dat Sanitizing Products Hand Sanitizer, 1 gallon (128 fl. oz.) 80% Alcohol, OTC, Manufactured by: Lula Holdings LLC, 15532 St. Charles Avenue, New Orleans, LA, NDC 77348-001-02.

Lula Holdings L.L.C.

CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits.

April 5, 2022 · DrugView details →

Class IICompleted

Trulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80

Cardinal Health Inc.

TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions

April 5, 2022 · DrugView details →

Class ICompleted

Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box, Marketed by Lilly USA, LLC, Indianapolis, IN 46285, Box NDC 0002-8799-59, Pen NDC 002-7516-59

Cardinal Health Inc.

TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.

April 5, 2022 · DrugView details →

Class IITerminated

PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081

North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

April 5, 2022 · DrugView details →

Class IITerminated

ARA-290 (Cibinetide Acetate) 6 mg/mL (4 mL) Injection, 4 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA

North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

April 5, 2022 · DrugView details →

Class IITerminated

Melanotan II 1 mg/mL (10 mL) Injection, 10mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA

North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

April 5, 2022 · DrugView details →

Class IITerminated

Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081

North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

April 5, 2022 · DrugView details →

Class IICompleted

Trulicity (dulaglutide) injection, 1.5 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 00002-1434-80

Cardinal Health Inc.

TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.

April 5, 2022 · DrugView details →

Class IITerminated

Sermorelin Acetate 1 mg/mL (6 mL) Injection, 6 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081

North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

April 5, 2022 · DrugView details →

Class IITerminated

BPC-157 2 mg/mL (5 mL) Injection, 5 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081

North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

April 5, 2022 · DrugView details →

Class IIITerminated

Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for Auromedics Pharma LLC, NDC 55150-364-01.

Aurobindo Pharma USA Inc.

Subpotent Drug: Out of Specification results for Assay

April 5, 2022 · DrugView details →

Class IITerminated

LL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA

North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

April 5, 2022 · DrugView details →

Class IITerminated

NB-243, Papaverine 30mg/ml . Phentolamine 3mg/ml . Alprostadil 20mcg/ml, 10ml Multi-Dose vials, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0009-10

Olympia Compounding Pharmacy dba Olympia Pharmacy

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

April 4, 2022 · DrugView details →

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