EU RASFF - Recalls For April 30th include Boron in lemon and redcurrant waters from Portugal, vegetarian sausages from the United Kingdom, almond kernels from the United States.
Tuesday, April 30, 2019
Norbrook Laboratories Expands Veterinary Products Recall, Adds Enroflox® 100 Injection (enrofloxacin), Noromectin® Injection (ivermectin), and Ivermax® 1% Injection (ivermectin).
Norbrook Laboratories Limited Expands Recall of Veterinary Products, to include Enroflox® 100
Injection (enrofloxacin), two lots of Noromectin® Injection (ivermectin)
and one lot of Ivermax® 1% Injection (ivermectin)
Summary
- Company Announcement Date:
- April 29, 2019
- FDA Publish Date:
- April 29, 2019
- Product Type:
- Animal & Veterinary
Animal Drugs - Reason for Announcement:
- Device & Drug Safety, Potential Lack of Sterility
- Company Name:
- Norbrook Laboratories Limited
- Brand Name:
- Norbrook Laboratories Limited
- Product Description:
- Subcutaneous injectable drug products
Company Announcement
Norbrook Laboratories Limited of Newry, Northern Ireland is expanding the recall of subcutaneous injectable drug products that began in early March 2019. Norbrook is adding to the recall four lots of Enroflox® 100 Injection (enrofloxacin), two lots of Noromectin® Injection (ivermectin) and one lot of Ivermax® 1% Injection (ivermectin) to the veterinarian/consumer level as a precautionary measure as product sterility cannot be assured. There is a concern that if the sterility of these products has been compromised, use of these products could result in introduction of infectious agents to the animal. This may result in the need for medical intervention(s) including, but not limited to the need for supportive care, antibiotics, and/or antifungal drugs.
As initially reported in early March 2019, Norbrook Laboratories Limited discovered that product tested, released and distributed within the USA was manufactured on an aseptic line that subsequently did not pass process simulation tests.
Enroflox® 100 Injection is an antimicrobial used for the treatment and control of bovine respiratory disease and for the treatment and control of swine respiratory disease.
Noromectin® Injection is a parasiticide used for the treatment and control of internal and external parasites in cattle and swine.
Ivermax® 1% Injection is a parasiticide used for the treatment and control of gastrointestinal roundworms, lungworms, lice, and mange mites in cattle and swine.
The products subject to recall are listed below. The product can be identified by checking the product name, manufacturer details and lot number on the carton or vial.
| NDC | Product Name, Strength and Package Size | Lot Number | Expiry Date |
|---|---|---|---|
| 55529-152-02 | Enroflox 100 (100 mg/mL; 100 mL vial) | 824190A | Jun 2021 |
| 55529-152-04 | Enroflox 100 (100 mg/mL; 250 mL vial) | 824290A | Jun 2021 |
| 55529-152-04 | Enroflox 100 (100 mg/mL; 250 mL vial) | 828392A | Jun 2021 |
| 55529-152-05 | Enroflox 100 (100 mg/mL; 500 mL vial) | 830193A | Jul 2020 |
| 55529-012-01 | Noromectin Injection (10 mg/mL; 50 mL vial) | 834595B | Aug 2021 |
| 55529-012-06 | Noromectin Injection (10 mg/mL; 1000 mL vial) | 834596A | Aug 2021 |
| 46066-917-01 | Ivermax 1% Injection (10 mg/mL; 50 mL vial) | 834595A | Aug 2021 |
Enroflox® 100 Injection, Noromectin® Injection and Ivermax® 1% Injection were distributed nationwide to Norbrook’s wholesale distributors. Norbrook Laboratories Limited is notifying its distributors by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Norbrook is arranging for return of all recalled products to the veterinarian/consumer level for a full refund. Instructions for returning recalled products are provided in the recall letter.
The Center for Veterinary Medicine recommends calling the drug company to report adverse drug experiences or product defects for FDA-approved animal products. The drug company responsible for the approved product is required to submit these reports to FDA. Contact Norbrook Laboratories Limited at 1-866-591-5777 Monday through Friday 9 am – 5 pm CST.
If you prefer to report directly to the FDA, you can submit Form FDA 1932a by following the link to the form found at https://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htmand following the instructions for emailing the completed form to FDA.
If you have a question about ADE reporting or need a paper copy of the form, contact CVM by email at AskCVM@fda.hhs.gov or by phone at 1-888-FDA-VETS (1-888-332-8387).
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).
Company Contact Information
- Consumers:
- Norbrook Laboratories Limited
- 866-591-5777
Jurox Inc. Recalls Alfaxan Unpreserved, an Intravenous Injectable Anaesthetic For Animals.
Jurox Incorporated is Voluntarily Recalling Two Lots of Alfaxan Unpreserved, an Intravenous Injectable Anaesthetic
Summary
- Company Announcement Date:
- April 24, 2019
- FDA Publish Date:
- April 27, 2019
- Product Type:
- Animal & Veterinary
Animal Drugs - Reason for Announcement:
- Device & Drug Safety, Defect
- Company Name:
- Jurox Incorporated
- Brand Name:
- Jurox
- Product Description:
- Alfaxan unpreserved, an intravenous injectable anaesthetic for cats and dogs
Company Announcement
| Vial size | Lot Number | Distributed from | Expiry |
|---|---|---|---|
| 10mL | #27787 | April 2017 | March 2020 |
| 10mL | #25955 | October 2016 | August 2019 |
This recall has been initiated due to an out of specification result for clarity observed in the stability program.
The presence of the aluminum phosphate precipitate presents a potential risk that intravascular (I.V.) injection of product containing this precipitate could result in blood vessel inflammation, and formation of blood clots or embolisms, which can be life threatening.
Jurox Incorporatedhas received two adverse event reports for lot #25955 and one adverse event report for lot #27787, involving five animals to date. Reasons for adverse event reporting included seizure, swelling of conjunctiva, respiratory arrest and a death.
Alfaxan unpreserved is an intravenous injectable anaesthetic for cats and dogs used in conjunction with other pre-anaesthetic medications. It is packaged into 10mL stoppered and crimped vials. The details of affected batches can be identified on the vial label and also on the base of the outer carton.
The affected batches were distributed throughout the USA to veterinary clinics through approved Jurox warehouses and distributors.
Jurox Incorporated has notified its warehouses and distributors by memo and email to locate any stock remaining of the recalled batches. Distributors and veterinarians that have any remaining vials of these two batches, which are being recalled, should quarantine the product to prevent use and contact Jurox to organize product replacement.
- The Center for Veterinary Medicine recommends calling the drug company to report adverse drug experiences or product defects for FDA-approved animal products. The drug company responsible for the approved product is required to submit these reports to FDA. Call Jurox byphone on either 816-698-6198 or 817-709-8845.
- If you prefer to report directly to the FDA, you can submit Form FDA 1932a by following the link to the form found at https://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055…and following the instructions for emailing the completed form to FDA.
- If you have a question about ADE reporting or need a paper copy of the form, contact CVM by email at AskCVM@fda.hhs.gov or by phone at 1-888-FDA-VETS (1-888-332-8387).
Distributors/veterinarians with questions regarding this recall can contact Jurox byphone on either 816-698-6198 or 817-709-8845, Monday to Friday from 9.00am to 5.00pm (CDT). Veterinarians should contact Jurox if they have experienced any problems that may be related to the use of these drug batches.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Company Contact Information
- Consumers:
- Mr Jim Van Proosdy
- 816-698-6198 or 817-709-8845
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