Drug Alerts and Statements
Alerts
FDA alerts health care professionals, patients, veterinarians and animal owners not to use sterile drug products from Ranier’s Compounding Laboratory
7/10/2018FDA advises consumers not to use Blissful Remedies kratom products due to bacterial contamination
7/5/2018FDA advises health care professionals not to use MedGyn Products’ Monsel’s Solution
6/29/2018FDA alerts health care professionals, patients, and the drug supply chain not to use stolen fertility drugs, Gonal-f RFF Redi-ject and Gonal-f Multi-Dose
5/30/2018FDA alerts health care professionals to voluntary nationwide recall of all sterile products from Coastal Meds
4/13/2018FDA alerts consumers of a nationwide voluntary recall of topical drug products made by Industria Farmacéutica Andrómaco due to contamination
3/30/2018FDA alerts consumers of Bayer’s voluntary recall of Alka-Seltzer Plus products due to labeling errors
3/16/2018FDA warns consumers not to use unapproved erectile dysfunction products advertised on the radio
3/16/2018FDA notifies health care professionals that Becton-Dickinson replaced problematic rubber stoppers in its syringes
1/12/2018FDA alerts health care professionals and patients not to use alcohol pads or benzalkonium chloride antiseptic towelettes manufactured by Foshan Flying Medical Products
9/1/2017FDA warns consumers about health risks of herbal coffee products from Malaysia containing undeclared active pharmaceutical ingredients and milk
8/21/2017FDA alerts health care professionals and patients not to use sterile drug products from Vital Rx, dba Atlantic Pharmacy and Compounding
8/10/2017FDA updates on 2017 Burkholderia cepacia contamination
8/8/2017FDA alerts health care professionals of adverse events associated with Guardian’s compounded triamcinolone and moxifloxacin product for intravitreal injection
7/28/2017FDA Updates on Multistate Outbreak of Burkholderia cepacia Infections
7/16/2016FDA advises health care professionals that counterfeit BiCNU has been discovered in some foreign countries
5/12/2016FDA announces Pharmakon Pharmaceuticals’ nationwide voluntary recall of purportedly sterile drug products
4/15/2016FDA issues three new draft guidances related to compounding of human drugs
4/15/2016- FDA alerts health care professionals and patients not to use sterile drug products from Medaus Pharmacy, Birmingham, Alabama
4/1/2016 FDA announces voluntary recall of all unexpired human and animal compounded drug products produced by Reliable Drug Pharmacy, San Francisco
3/30/2016- FDA Warns Consumers Not to Use “Best Bentonite Clay” Laboratory tests indicate elevated levels of lead
3/23/16 FDA Alerts Healthcare Professionals About Clinical Trials with Zydelig (idelalisib) in Combination with other Cancer Medicines
3/14/16FDA alerts health care professionals and patients not to use human and animal sterile drug products produced and distributed by I.V. Specialty, Ltd., Austin, Texas
3/9/2016FDA announces Pharmakon Pharmaceuticals voluntary recall of morphine sulfate 0.5 mg/mL preservative free in 0.9% sodium chloride
2/16/2016FDA alerts compounding pharmacies of a nationwide voluntary recall of Syrspend SF and Syrspend SF Grape suspending agents from Fagron Inc., due to microbial contamination with yeast
2/10/2016FDA warns consumers about health risks with Alikay Naturals – Bentonite Me Baby – Bentonite Clay
1/28/2016FDA Warns Consumers Not to Use Viansilk’s “Crema Piel De Seda” (“Silky Skin Cream”)
1/28/2016FDA Warns Consumers Not to Use Licorice Coughing Liquid
1/15/2016FDA working with manufacturers to withdraw Zinbryta from the market in the United States As a result, the FDA is working closely with the manufacturers to help ensure a well-organized withdrawal from the market in the United States, and to ensure that health care professionals have the information they need to carefully transition their...
Statements
- FDA Approves Labeling Supplement for Celebrex (celecoxib)
6/28/2018 FDA Withdraws Draft Guidance for Industry: Statistical Approaches to Evaluate Analytical Similarity
6/21/2018FDA video series about biosimilar and interchangeable products
5/22/2018FDA Alerts Health Care Professionals and Oncology Clinical Investigators about an Efficacy Issue Identified in Clinical Trials for Some Patients Taking Keytruda (pembrolizumab) or Tecentriq (atezolizumab) as Monotherapy to Treat Urothelial Cancer with Low Expression of PD-L1
5/18/2018FDA reports quality problems for data provided by the firm IQVIA that were used to inform estimates for some controlled substances
5/16/2018FDA working with manufacturers to withdraw Zinbryta from the market in the United States
3/14/2018FDA reminds pharmaceutical industry of new drug listing certification requirement due December 31, 2017
12/14/2017FDA works to help relieve the IV fluid shortages in wake of Hurricane Maria
11/14/2017CDER Statement: FDA updates on Pfizer drug shortages
11/9/2017FDA warns Meridian Medical Technologies about CGMP violations associated with the manufacture of EpiPen
9/8/2017FDA Alerts Healthcare Professionals and Oncology Clinical Investigators about Two Clinical Trials on Hold Evaluating KEYTRUDA® (pembrolizumab) in Patients with Multiple Myeloma
8/31/2017FDA warns consumers not to use Balguti Kesaria Ayurvedic Medicine due to high levels of lead
8/4/2017FDA issues warning about body-building products labeled to contain steroid and steroid-like substances
6/20/2017FDA advises drug manufacturers that Burkholderia cepacia complex poses a contamination risk in non-sterile, water-based drug products
5/22/2017FDA announces Standard Homeopathic Company’s nationwide voluntary recall of Hyland’s teething tablets
4/13/2017- FDA approves a generic of Xyrem with a REMS Program
1/17/2017 FDA Issues Final Guidance on Repackaging and Revised Draft Guidance on Mixing, Diluting, and Repackaging Biological Products
1/12/2017FDA warns cancer patients not to use PNC-27 products for treatment
1/10/2017Impact of Exclusivity on Approval of Arymo ER
1/9/2017FDA issues guidance on prescription requirement under section 503A
12/28/2016FDA Issues Draft Guidances on Compounding and Repackaging Radiopharmaceuticals
12/28/2016FDA proposes six bulk drug substances for inclusion on the 503A bulks list
12/15/2016FDA approves new changes to testosterone labeling regarding the risks associated with abuse and dependence of testosterone and other anabolic androgenic steroids (AAS)
10/25/2016Proposed rule to amend the list of drug products that may not be compounded because they have been withdrawn or removed from the market for safety and effectiveness reasons
10/17/2016FDA analyses conclude that Xarelto clinical trial results were not affected by faulty monitoring device
10/11/16Final rule amending list of drug products that may not be compounded because they have been withdrawn or removed from the market for safety or effectiveness reasons
10/6/2016FDA finds drugs under investigation in the U.S. related to French BIA 10-2474 drug do not pose similar safety risks
8/12/2016FDA issues draft guidance on insanitary conditions at compounding facilities
8/3/2016FDA approves a dedicated syringe to be used with Humulin R U-500 insulin
7/8/2016FDA issues proposals to implement statutory restrictions on compounding drugs that are essentially copies of commercially available or approved drugs
7/7/2016Update: FDA revises final guidances on interim policy for certain bulk drug substances used in compounding
6/9/2016Neonatal opioid withdrawal syndrome and medication-assisted treatment with methadone and buprenorphine
5/26/2016FDA warns consumers about potential risks of using eye drops packaged in bottles with loose safety seals
3/15/2016FDA finds drugs under investigation in the U.S. related to French BIA 10-2474 drug do not pose similar safety risks
1/22/2016