Adverse Events and Recalls

Commissioner Scott Gottlieb issued a statement warning about the risks associated with kratom.

The voluntary recall is due to blister packages containing the incorrect product.

The company is recalling several injectable products because of possible microbial contamination.

Both regulatory bodies are working on enhancements to their respective adverse event reporting systems in efforts to increase transparency and safety monitoring of drugs.

Pharmaceutical companies should prepare for the impact of recalls to minimize risk to consumers and the company.

FDA has put out an alert regarding the risks associated with using Keytruda in combination with other anti-cancer drugs based on interim results from two clinical trials that showed increased risk of death.

Hospira, a Pfizer company, is voluntarily recalling one lot of vancomycin hydrochloride for injection, USP, 750 mg/vial because of glass within a single vial.

The company is voluntarily recalling the products because of potential contamination with Burkholderia cepacia.

The company is voluntarily recalling Lorazepam Oral Concentrate, USP 2mg/mL because of misprinted dosing droppers.

On August 10, 2017, FDA announced a voluntary recall of all liquid products manufactured by PharmaTech and distributed by Leader Brand, Major Pharmaceuticals and Rugby Laboratories because of possible Burkholderia cepacia (B. cepacia) contamination.

Stainless-steel particulates were found in one lot of 0.9% Sodium Chloride Injection, USP 1000 mL, prompting the recall to the hospital/user level.

Apace Packaging LLC labeling error initiates national recall of cyclobenzaprine HCL and amantadine HCL (Lot 16710).

The company is voluntarily recalling Sten Z and M1 Alpha capsules because the product contains derivatives of anabolic steroids, which makes them unapproved drugs.

Fagron Sterile Services has voluntarily recalled three lots of Succinylcholine Chloride 20mg/mL 5mL syringe to the hospital/clinic level.

The company has voluntarily recalled Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level because of a lack of sterility assurance.

The company is voluntarily recalling all unexpired lots of nitroglycerin products produced at its Houston location for potency issues.

The company recalled a variety of products due to the potential of microbial contamination.

The company has extended its voluntarily recall of one lot of paliperidone extended-release tablets to the consumer level due to dissolution test failure.

The company is voluntarily recalling one lot of Eliquis after a patient discovered that a bottle labeled as Eliquis 5 mg was found to contain Eliquis 2.5 mg tablets.

The company recalled the tablets due to a packaging error.

The company voluntarily recalled one lot of Brilinta 90 mg professional samples because it contained another medicine.

The agency is warning drug manufacturers about Burkholderia cepacia complex after product recalls due to contamination.

Truxton, Inc. is voluntarily recalling one lot of Phenobarbital Tablets, USP, 15 mg because of a labeling error on declared strength.

The company is recalling one lot of 25% Dextrose injection after particulate matter was found within an internal sample syringe.

Standard Homeopathic Company is recalling all lots of Hyland’s Baby Teething Tablets and Hyland’s Nighttime Baby Teething Tablets due to inconsistent amounts of belladonna alkaloids.

The recall was issued because of a defective delivery system; the units affected had possible package leakage.

The company announced that Meridian Medical Technologies is extending a recall of EpiPen and EpiPen Junior to the United States.

Avella issued a nationwide recall of sterile products produced at the Advanced Pharma Houston location due to inaccurate labeling.

The company is voluntarily recalling one lot of Edex due to a lack of container closure integrity.

The company has voluntarily recalled all lots of of human chorionic gonadotropin because of a lack of sterility assurance.