FREQUENTLY ASKED QUESTIONS

Q. Can I buy products directly from Mallinckrodt?
A. We do not sell directly to patients or your local pharmacy. Your pharmacist can purchase Mallinckrodt products from a pharmaceutical distributor in their area.
 
Q. Who should I contact regarding a question or concern I have with my medication?
A. Please contact our Product Monitoring group at 800.778.7898 with any product questions. You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit http://www.fda.gov/medwatch, or call 800.FDA.1088.

Q. Where are your products made?
A. The majority of the raw materials and finished dosage forms (tablets, capsules, liquids, etc.) for Mallinckrodt’s generic business are made in the United States.

Q. What are generic drugs?
A. A generic drug is the same as the brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. The generic drugs must meet FDA requirements for bioequivalence. This means the drug is delivered at the same rate and extent in order to be considered comparable to the branded product.
 
Q. Will my generic drug be as effective as the branded drug?
A. A generic drug is the same as a brand-name drug in dosage, safety, strength, quality, the way it works, the way it is taken and the way it should be used.

Q. I received your generic which looks different from what I took in the past. Is it the same as my other drug?
A. First, make sure you received the correct medication. It is listed on the prescription label. If you are unsure if your prescription is correct, please contact your pharmacist for verification. You may also search our website for product descriptions. Generic drugs must be equivalent to the brand name drug in quality, strength, purity and stability but can differ in color, shape, size and markings.
 
Q. I used a fentanyl patch and it did not stay on my skin, what can I do?
A. This can happen with patches as every skin type varies. Please review the package insert regarding techniques available to assist in adhesion of your transdermal system.
Please contact our Product Monitoring group by phone at 800.778.7898 or via email: PMquality@mnk.com 
 
Q. Are Mallinckrodt products latex and gluten free?
A. Please contact our Product Monitoring group at 800.778.7898 for questions pertaining to product ingredients.
 
Q. I could not get my Mallinckrodt prescription filled. The pharmacist said it was because of a DEA quota shortfall. How does that affect me?
The DEA sets total annual requirements, called quotas, for manufacturing controlled substances. Each manufacturer is given a set amount of quota for manufacturing and selling their controlled substances. If the DEA determines there is enough of the product available in the market to meet patient needs, it may reduce these amounts.

Q. My pharmacist said I had to register to obtain my medication. Why is that?
A. FDA requires manufacturers of certain drugs to have a Risk Evaluation and Mitigation Strategy (REMS) to provide education, training and tools in an effort to reduce the risks associated with those drugs, We, as an organization, strongly advocate of proper prescribing, dispensing and taking of medication. You may have been asked to register to ensure you are appropriately prescribed the medication. For more information on REMS please visit the FDA website at http://www.er-la-opioidrems.com/IwgUI/rems/products.action