Akorn, Inc. recalls Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, packaged in a) 20mL vials and b) 30 mL vials, Rx Only,…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Read the official notice →- Date
- 2023-06-07
- Country
- United States
- Brand
- Akorn
- Product
- Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, packaged in a) 20mL vials and b) 30 mL vials, Rx Only,…
- Classification
- Class II
- Units
- Nationwide in the USA and Puerto Rico
- Category
- Drugs & medical
- Source
- FDA · Drug
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Akorn recalls
- 2023-02-15
USAkorn, Inc. recalls Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn…
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
- 2023-01-25
- US
- 2022-10-05
- US
Akorn, Inc. recalls Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031, NDC 61748-015-30
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
- 2022-09-14
- US
Akorn, Inc. recalls Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
- 2022-09-07
- US
Akorn, Inc recalls Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake…
Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
- 2022-08-24
- US
Akorn, Inc recalls PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-042-24
Defective Container: Product has incomplete induction seals.
Other drugs & medical recalls in the United States
- 2023-06-07
- US
Maquet Medical Systems USA recalls QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may…
- US
Trophy SAS recalls CS¿9600¿is¿an¿extraoral¿system¿intended¿to¿produce¿two-dimensional¿and¿three-dimensional¿digital¿X-ray¿images¿of¿the¿dento-maxilofacial,¿EN…
Device failed to function as intended and/or failed to conform to their design specifications.
- US
Novis PR, LLC dba Kramer Novis recalls G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric Drops Cough Suppressant Expectorant Nasal…
Product mix-up: incorrect product was found inside the G-Supress DX product carton.
- US
New England Life Care, Inc. dba Advanced Compounding… recalls Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced…
Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
FDA · DrugNew England Life Care, Inc. dba Advanced Compounding…Nationwide in the USA.Official notice → - US
Fresenius Medical Care Holdings, Inc. recalls Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America,…
Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
FDA · DrugFresenius Medical Care Holdings, Inc.Product was distributed to 32 clinics in SC, NC and VA.Official notice → - US
SSM Health Care St. Louis DBA SSM St. Clare Health Center recalls HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care…
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
FDA · DrugSSM Health Care St. Louis DBA SSM St. Clare Health CenterProduct was distributed in Missouri.Official notice →