Drug Alerts and Statements
Alerts
FDA 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
1/15/2016
Statements
FDA issues warning about body-building products labeled to contain steroid and steroid-like substances
6/20/2017CDER Statement: FDA updates on Pfizer drug shortages
6/15/2017FDA 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1/17/2017 FDA Issues Final Guidance on Repackaging and Revised Draft Guidance on Mixing, Diluting, and Repackaging Biological Products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