The U.S. Food and Drug Administration (FDA) has announced several
recalls and took actions regarding OxyContin for the period of April 1 through
April 17, 2013. Consumers should make sure they are not using any of the recalled
products. In addition, OxyContin users should be aware of these latest actions including banning the use and sale of generic OxyContin.
Here is a list of FDA announced recalls for the period of April 1 to April 17, 2013 (organized by: Date | Brand Name | Product Description | Reason/ Problem | Company):
On April 16, 2017, the FDA took several actions regarding OxyContin, including:
The
FDA is an agency within the U.S. Department of Health and Human Services whose job is to protect the public by assuring the "safety, effectiveness, and security" of many items, including food, drugs, supplemental and medications.
Here is a list of FDA announced recalls for the period of April 1 to April 17, 2013 (organized by: Date | Brand Name | Product Description | Reason/ Problem | Company):
- 4/01/2013 | ROCK-IT-MAN | Male sexual enhancement capsules | Product contains hydroxythiohomosildenafil, an analogue of sildenafil | Consumer Concepts, Inc.
- 4/03/2013 | Bravo! | Chicken Balance, Chicken Blend and Beef Blend Burgers | Raw Frozen Food Diet for Dogs and Cats | Potential to be contaminated with Salmonella | Bravo!
- 4/4/2013 | Little Mermaid Smoke House | Smoked Herring and Pickled Herring fish | Products were found to be uneviscerated, and have the potential to be contaminated with Clostridium botulinum | Little Mermaid Smoke House
- 4/4/2013 | Farm Rich, Market Day, Schwan's | Mozzarella bites, quesadillas, pizza slices and more | Escherichia coli O121 | Rich Products Corporation
- 4/4/2013 | Centerville Pie | Clam Pies | Undeclared fish (anchovies) | Centerville Pie Company
- 4/05/2013 | Green Valley Drugs | Sterile, compounded products | Lack of sterility assurance and concerns associated with the quality control processes | Green Valley Drugs
- 4/10/2013 | Affirm XL | Dietary supplement | Contain an analogue of sildenafil | Affirm XL
- 4/10/2013 | Stryker Corporation | ShapeMatch Cutting Guides | Due to the potential that ShapeMatch Cutting Guides may not have been manufactured in accordance with surgeon preoperative planning parameters or may have been manufactured outside of the planning ranges specified in the 510(k) clearance | Stryker Corporation
- 4/12/2013 | Chappaqua Crunch | Simply Granola with Flax and Fruit (Gluten Free) | Undeclared Almonds | Wild Blue Yonder Foods
- 4/12/2013 | Winn Dixie | Apple Juice | May contain elevated levels of patulin. | Winn Dixie
- 4/15/2013 | NuVision Pharmacy | Lyophilized compounds HcG 5000IU-5ml and Sermorelin/GHRH6-5ml | Lack of sterility assurance NuVision Pharmacy
- 4/15/2013 | ApothéCure | Sterile drug products | Lack of sterility assurance | ApothéCure Inc.
- 4/15/2013 | O Organics | Enchiladas | Undeclared milk | Cedarlane Natural Foods, Inc.
- 4/16/2013 | Wegmans | Roasted Red Pepper Dip | Undeclared Eggs and Milk | Wegmans Food Markets
- 4/17/2013 | Latis | Herring and Salmon | Listeria monocytogenes | Prime Food USA
Source
and for more information: Recalls, Market Withdrawals, & Safety Alerts (as of April 18, 2013)
OxyContin is a prescription narcotic pain reliever manufactured by Purdue Pharma L.P., with the active ingredient of oxycodone, a derivative of opium. It can be highly addictive and misused.
On April 16, 2017, the FDA took several actions regarding OxyContin, including:
- Will not accept or approve any abbreviated new drug applications (generics) that rely upon the approval of original OxyContin (Purdue Pharma had previously released a reformulated OxyContin replacing its original)- this effectively bans generic OxyContin.
- Approved updated labeling that indicates that the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting).
- Determined that reformulated OxyContin has sufficient abuse-deterrent properties although it will not prevent all abuse. Specifically, the tablets are more difficult to crush, break, or dissolve as well as forming a viscous hydrogel that cannot be easily prepared for injection.
The Press Release announcing these OxyContin actions included the following
statement:
The FDA, together with other public health agencies, continues to encourage the development of abuse-deterrent formulations of opioids and believes that such products will help reduce prescription drug abuse. At the same time, the FDA remains committed to ensuring that patients with pain have appropriate access to opioid analgesics.
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