FDA Archives - Newsome

Park Pharmacy & Compounding Center Recalls Two Lots of Sterile Preparations

Thursday, August 29, 2013 - 01:32

The Food & Drug Administration has discovered many issues with drug products that are meant to be sterile this year. The issues have often occurred at compounding pharmacies, which create specialized medical products for patients with unique needs. For instance, Specialty Compounding recently recalled all of its sterile medications due to reports about bacterial infections. Now, another compounding pharmacy is having issues with sterility assurance. Due to unclear lab methods used to test sterility, Park Pharmacy & Compounding Center is recalling two lots of Methylcobalamin and Multitrace-5 Concentrate vials.

According to the FDA, investigators have discovered that the pharmacies may have received inaccurate laboratory test results due to the manner in which sterility was assessed. The method of testing led to the FDA questioning if the results obtained by the laboratory are reliable. Park Pharmacy & Compounding Center states that “there have been no reported adverse events associated with the use of these products and there has been no confirmation of lack of sterility of these products.” However, if microbial contamination exists in the products that are intended to be sterile, then patients can contract life threatening bacterial infections.

The recall affects injectable forms of Methylcobalamin 5mg/ml 30ml Amber Vials Lot #06132013@1 Exp: 12/10/2013 and Multitrace-5 Concentrate 10ml Amber Vials Lot #05212013@20 Exp: 11/17/2013. The products are high doses of specific vitamins and minerals. According to Mayo Clinic, Methylcobalamin is a form of Vitamin B-12. The recalled products were sold directly to customers or to physician offices in June and July 2013. The products were only sold in California, Florida, New Mexico and Indiana.

Currently, the company is preparing for the return of all recalled product lots and is informing customers about the recall. The company recommends that consumers stop using the recalled products and contact the company for information on returning any unused product. Consumers can contact Park Pharmacy & Compounding at 949-551-7195 or by email at info@parkrx.com weekdays 9 a.m. to 5 p.m. PST.

Defective & Dangerous Drugs

FDA Warns Consumers about Potential Hazards of Laser Toys

Friday, August 9, 2013 - 06:14

Over the past few years, consumers have become more aware of potential hazards to young children, especially with toys. The CPSC often discovers that popular children’s products can be dangerous if handled improperly.

Children's Products

FDA Class I Recall Issued for Medtronic Minimed Paradigm Insulin Infusion Sets

Wednesday, July 17, 2013 - 12:45

It goes without saying that flawed medications are often very dangerous for consumers. Earlier this month, a large drug product manufacturer, Fresenius Kabi, recalled four lots of Benztropine Mesylate Injections due to the risk of tiny clear particulates existing in the glass vials, posing a safety risk to consumers. This week, another large drug manufacturer issued a recall for a defective medical product.

Defective Medical Devices

Recall Of Generic Vicodin: FDA Announces Recall Over Concerns Of Overdose

Tuesday, December 11, 2012 - 03:23

In the wake of the news of recalls and poor production methods and conditions out of Ranbaxy Laboratories in India, the U.S. Food and Drug Administration has announced the recall of another popular generic medication over concerns that it could lead to overdose.

Defective & Dangerous Drugs

FDA Announces Removal of Generic Wellbutrin XL 300 mg

Tuesday, October 16, 2012 - 09:05

Part of the process of achieving Food and Drug Administration approval for prescription medication is the clinical trial. During a clinical trial, the drug will be tested multiple times to determine whether it works and if it has any side effects. To determine this information, the drug is tested against a placebo so accurate comparisons can be made, and a placebo, of course, is simply nothing more than an inert pill. But it’s important to realize that while placebos are meant to do absolutely nothing, prescription drugs are actually supposed to do something.

Defective & Dangerous Drugs

FDA Enough to Protect Consumers After Tainted Orange Juice Scare?

Thursday, January 19, 2012 - 07:03

Last week Coca-Cola said it “alerted the Food and Drug Administration after it discovered via testing its own and competitors’ products that some Brazilian growers had sprayed their orange trees with a fungicide that is not approved for use in the U.S.,” the Associated Press reports. Despite being banned for use in the U.S., this fungicide, known as carbendazim, is still used in Brazil.

Food Recall

Actos Multidistrict Litigation Pending As EMA And FDA Still Pushing Drug As Second Line Treatment

Monday, October 31, 2011 - 06:53

The European Medicines Agency has recently announced that, despite a serious risk for causing bladder cancer, the prescription medication Actos – or Glustin as it is known in some European countries – should still be prescribed by physicians as a second or third line treatment option for patients suffering from Type 2 diabetes. The EMA – as well as the U.S. Food and Drug Administration – contended as recently as July 2011 that Actos createded a greater risk of bladder cancer to patients using the drugs than those not using them.

Defective & Dangerous Drugs

According To FDA Report, J&J Plant Still Has Quality Control Issues

Friday, December 17, 2010 - 08:57

According to a Daily Finance news story released yesterday, regulators revealed that Johnson & Johnson “still hasn’t solved all the problems at the Pennsylvania plant largely responsible for a huge recall of children’s medicine earlier this year.”

Product Liability

FDA Warns Cough Capsule Poses Alleged Risk To Children

Thursday, December 16, 2010 - 07:26

PR Newswire reports that the U.S. Food and Drug Administration alleges some cough capsules pose a risk to young children. According to the FDA, the “accidental ingestion of Tessalon (benzonatate) by children younger than 10 years can result in serious side effects or death,” the Newswire reports.

Children's Products

“Significant Violations” Still Found By FDA At Johnson & Johnson Manufacturing Plant

Friday, December 3, 2010 - 07:40

The Wall Street Journal reports that the U.S. Food and Drug Administration again cited the pharmaceutical manufacturer, Johnson & Johnson. This time, the FDA found that during an inspection of a Puerto Rico manufacturing plant, the drug maker had “various deficiencies.”