Akorn, Inc. recalls Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by:…
CGMP Deviations:
Read the official notice →- Date
- 2023-01-25
- Country
- United States
- Brand
- Akorn
- Product
- Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by:…
- Classification
- Class II
- Units
- Nationwide in the USA
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
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- 2023-06-07
USAkorn, 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.
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Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
- 2022-10-05
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Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
- 2022-09-14
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- 2022-09-07
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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
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Other drugs & medical recalls in the United States
- 2023-01-25
- US
MACLEODS PHARMA USA, INC recalls Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540;…
Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
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Lannett Company Inc. recalls Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [100 or 1000 ] Capsules per bottle, Distributed by: Lannett…
Failed Impurity/Degradation Specifications
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Ascend Laboratories, LLC recalls Rasagiline Mesylate Tablets 1 mg; 30 tablets in HDPE bottle; Rx only; NDC 67877-260-30; Manufactured by Alkem Laboratories Ltd., India;…
Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
FDA · DrugAscend Laboratories, LLCCustomers in 19 states: CA, FL, GA, IL, KY, LA, MI, MN, MS, NC, NJ, NY, OH,…Official notice → - US
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Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
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The product is labeled with the incorrect expiration date.