AuroMedics Pharma LLC recalls Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E.…
Presence of Particulate Matter: Piece of metal found in a vial
Read the official notice →- Date
- 2022-10-12
- Country
- United States
- Brand
- AuroMedics Pharma
- Product
- Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E.…
- Classification
- Class III
- Units
- Distributed 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
More AuroMedics Pharma recalls
- 2022-11-02
USAuroMedics Pharma LLC recalls Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharma LLC 279…
Subpotent Drug: Out of specification for assay
- 2022-10-26
- US
AuroMedics Pharma LLC recalls Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279…
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
- 2022-02-16
- US
AuroMedics Pharma LLC recalls Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only, Distributed by:…
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Other drugs & medical recalls in the United States
- 2022-10-12
- US
Philips North America Llc recalls MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Device may intermittently fail to produce audio. Turning the unit off and on does not resolve the issue; disconnecting and reconnecting to AC power does not reliably resolve the issue.
FDA · DevicePhilips North America LlcDomestic distribution to AL AZ CA CO FL GA ID IL IN LA MA MI MN NC NE NJ OH PA…Official notice → - US
- US
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does…
- US
CIPLA recalls Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dose Vials per pouch,…
Lack of Assurance of Sterility: environmental monitoring failure.
FDA · DrugCIPLAProduct was distributed nationwide to distributors/wholesalers who may have…Official notice → - US
Dr. Reddy's Laboratories, Inc. recalls Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's…
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
- US
Woodbine Products Co Inc recalls Antibacterial Foaming Wash with Hydria Moisturizing Formula, Cucumber-Melon Scent, 1250 mL (42 fl oz.), Manufactured for: Triple S,…
Labeling: Not Elsewhere Classified - Incorrect label-incorrect scent listed on label.