Dipyridamole Tablets

Do the tablets contain Gluten?

No.

Do the tablets contain Soy?

No.

The imprint is inconsistent? Has the imprint changed? What is the correct imprint?

When first introduced into the market, all three strengths of Dipyridamole tablets carried the "G12" imprint. Although all three purple tablets were different sizes this caused confusion. Therefore in early 2007 the imprints were revised to carry three unique imprints: 25 mg "G12", 50 mg "G91" and 75 mg "G92". Although the imprints have changed, older product will still be in the marketplace until exhausted or expired.

Fluconazole Tablets

I read that a single 150 mg tablet should be sufficient to cure my yeast infection, however my doctor has prescribed multiple pills? Given me an extra to take in a week if infection is not gone?

While the standard dosing of one 150 mg tablet/day should not be exceeded on a daily basis, physicians often provide additional doses to patients with individual instructions on how and when to dose.

Can Fluconazole be taken by men?

Yes.  Fluconazole is commonly prescribed for men.

Do the tablets contain Lactose?

No.

Do the tablets contain Soy?

No.

Gabapentin Tablets

Do the tablets contain Gluten?

No.

Do the tablets contain Food dye?

No, only titanium dioxide is used for coloring.

Meloxicam Tablets

Do the tablets contain Gluten?

No.

Do the tablets contain Lactose?

Yes.

Naproxen Tablets

Do the tablets contain Gluten?

No.

Do the tablets contain Lactose?

No.

Do the tablets contain Soy?

No.

There are different imprints on tablets from multiple bottles of product?

Glenmark distributes Naproxen Tablets from multiple manufacturers under the Glenmark name.  For this reason there will be multiple imprints in the  marketplace, however any given bottle will have only one imprint and that imprint will match the description in attached PI with each shipment.

Nitroglycerin Sublingual Tablets

Patient does not feel a tingle, zip, pop, sting, etc. Are these active and potent tablets?

The tingle does not indicate potency and is actually due to the presence of a degradant, explaining the older products ability to tingle. The FDA/USP are aware and the approved PI indicates that the tingle is only a possibility and should not be relied upon for potency or effect. Today's Nitroglycerin tablets may dissolve slightly slower, but are more stable.

Are the tablets good through the expiration date? Once opened should the tablets be discarded in a month?

Today's Nitroglycerin tablets are far more stable than those of the past and as long as they are kept in the original brown vial and kept tightly sealed they can be expected to remain potent through expiration.

Why is this being recalled?

The product has not been recalled. As there is an approved NDA the FDA is requiring Glenmark to exit the market until a time that an application is submitted and approved.

Is the product safe to take?

Yes. The FDA has not cited an deficiencies in the safety or effectiveness of the product. It is for that reason that the product is being permitted to stay on the market for a given time.

Can I continue to take the medication I have after the time when your company stops selling?

Yes, all product can be used throughout the expiration date. That has not changed.

Where can I get my medication moving forward?

For the time being Glenmark’s product will remain available. After that time, your pharmacy will be responsible for obtaining product from an alternate source. If you have additional questions your pharmacist will be best equipped to answer those questions.

Can I return what I have for a refund?

All refund requests need to be directed to your point of purchase. More details about our returned good procedure may be found on our website. The product is safe and effective.

Is your company filing an application?

At this time we cannot comment on our business plans.

Has Glenmark released any information to the public on their nitroglycerin sublingual tablets?

Yes, please see the attached announcement from Glenmark regarding their action plan for nitroglycerin.
Link to pdf

Ondansetron HCl

Do the tablets contain Gluten?

No.

Do the tablets contain Lactose?

Yes.

Ondansetron ODT

Do the tablets contain Gluten?

No.

Do the tablets contain Lactose?

No.

Pravastatin Sodium Tablets

Do the tablets contain Gluten?

No.

Do the tablets contain Lactose?

No.

Terbinafine HCl Tablets

Do the tablets contain Lactose?

No.

The imprint is inconsistent? Has the imprint changed? What is the correct imprint?

Glenmark distributes Terbinafine Tablets made by two manufacturers under the Glenmark label.  The 30's count bottle material is manufactured by an 3rd party and tablets reflect an  imprint of "IG209".  The remaining bottle sizes utilize Glenmark manufactureed material an reflect an imprint of "G250".  The package inserts are specific and reflect the correct imprints.

Zonisamide Capsules

Can the capsules be opened? Broken? Sprinkled in applesauce? Mixed with Juice? Made into a solution?

The package insert indicates that these capsules should not be opened, bitten or crushed.  Glenmark is not able to provide additional information on alternate dosing regimens.  Patients and caregivers are encouraged to check with the manufacturer of the Brand product for any changes or updates.

Do the tablets contain Gluten?

No.

Do the tablets contain Lactose?

No.