24 hours ago · In a significant decision, the Tenth Circuit on Monday revived a whistleblower's False ...
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Tuesday, July 10, 2018
FDA alerts health care professionals, patients, veterinarians and animal owners not to use sterile drug products from Ranier’s Compounding Laboratory
he U.S. Food and Drug Administration is alerting health care professionals and patients, as well as veterinarians and animal owners, not to use human and animal drug products intended to be sterile that are produced and distributed by Ranier’s Compounding Laboratory, also doing business as Ranier’s Pharmacy and Ranier’s RX Laboratory, Jeannette, Pennsylvania, due to lack of sterility assurance.
Health care professionals and veterinarians should immediately check their medical supplies, quarantine any purportedly sterile drug products, and not administer them to patients. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.
FDA issued a warning letter to Ranier’s Compounding in March 2017 following an inspection. During FDA’s recent follow-up inspection of Ranier’s compounding facility, investigators observed insanitary conditions, including poor sterile production practices, which raised concerns about the company’s ability to assure the sterility of its drug products.
On June 6, 2018, FDA recommended that Ranier’s Compounding recall all unexpired human and animal drug products intended to be sterile and to cease sterile operations until it makes adequate corrections at its facility. On June 7, 2018, Ranier’s Pharmacy informed FDA that it agreed to voluntarily recall and cease sterile operations. However, the company has failed to comply with its commitment.
To date, FDA is not aware of any adverse events associated with the use of products from Ranier’s Compounding. Patients who have received drug products produced by Ranier’s Compounding and have concerns should contact their health care professional.
FDA encourages health care professionals and patients to report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program by:
Health care professionals and veterinarians should immediately check their medical supplies, quarantine any purportedly sterile drug products, and not administer them to patients. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.
FDA issued a warning letter to Ranier’s Compounding in March 2017 following an inspection. During FDA’s recent follow-up inspection of Ranier’s compounding facility, investigators observed insanitary conditions, including poor sterile production practices, which raised concerns about the company’s ability to assure the sterility of its drug products.
On June 6, 2018, FDA recommended that Ranier’s Compounding recall all unexpired human and animal drug products intended to be sterile and to cease sterile operations until it makes adequate corrections at its facility. On June 7, 2018, Ranier’s Pharmacy informed FDA that it agreed to voluntarily recall and cease sterile operations. However, the company has failed to comply with its commitment.
To date, FDA is not aware of any adverse events associated with the use of products from Ranier’s Compounding. Patients who have received drug products produced by Ranier’s Compounding and have concerns should contact their health care professional.
FDA encourages health care professionals and patients to report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program by:
- Completing and submitting the report online at www.fda.gov/medwatch/report.htm; or
- Downloading and completing the form, then submit it via fax at 1-800-FDA-0178.
Federal judge enters consent decree against Minnesota dairy farm for drug residue violations
| |||
| 05/31/2018 | Jacobs Pills, Inc. | New Jersey District Office | Compounding Pharmacy/Adulterated Drug Products | Not Issued |
Subscribe to:
Posts (Atom)