Norgestimate and Ethinyl Estradiol Tablets
This notice is to inform you that on 2/27/12, the U.S. Food and Drug Administration (FDA) announced that the manufacturer, Glenmark Generics, Inc., issued a recall of seven (7) lots of Norgestimate and Ethinyl Estradiol Tablets USP (0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg). Norgestimate and Ethinyl Estradiol Tablets are used as an oral contraceptive, indicated for the prevention of pregnancy in women.
This recall was initiated because of a packaging error where select blister packs were rotated 180 degrees within the card, reversing the weekly tablet orientation. As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy. Following is the list of lot numbers that are included in this recall.
| Lot Numbers |
Expiration Date |
| 04110101 |
07/31/2013 |
| 04110106 |
07/31/2013 |
| 04110107 |
07/31/2013 |
| 04110114 |
08/31/2013 |
| 04110124 |
08/31/2013 |
| 04110129 |
08/31/2013 |
| 04110134 |
08/31/2013 |
| 04110114 |
08/31/2013 |
If your prescription has a lot number listed above, it is recommended that you notify your physician and return the product to the pharmacy.
Albuterol
This notice is to inform you that on 1/3/11, the U.S. Food and Drug Administration (FDA)
announced that the manufacturer The Ritedose Corporation initiated a voluntary recall
of 0.083% Albuterol Sulfate Inhalation Solution, 3 mL (in 25, 30, and 60 unit dose vials).
This product is a prescription inhalation solution, administered via a nebulizer.
It is being recalled because single use vials are embossed with the wrong concentration
of medication and could result in a range of potential health effects that span from
temporary and medically reversible to life threatening. We recommend that you immediately
return the affected product to the place you obtained it (ie. pharmacy, doctor's office).
For more information concerning this recall you may contact The Ritedose Corporation
at 803-935-3995 Monday through Friday, 8am to 5 pm EST, or by e-mail at
recall@ritedose.com.
Darvocet
On 11/19/10, the U.S. Food and Drug Administration (FDA) announced that the manufacturer Xanodyne Pharmaceuticals, Inc. initiated a voluntary recall of its Darvon, Darvon-N and Darvocet products. This withdrawal applies to all propoxyphene-containing products, affecting brand and generic pharmaceutical companies. Propoxyphene is used to treat mild-to-moderate pain and has been on the market for the last 50 years. The recall is due to new clinical data which shows that the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities. The FDA concluded that the safety risks of propoxyphene outweigh its benefit for pain relief.
Information regarding this recall can also be found at www.xanodyne.com or by calling the medical information line at
1-877-773-7793.
Methotrexate
This notice is to inform you that on 10/29/10, the U.S. Food and Drug Administration
(FDA) announced that the manufacturer Sandoz, Inc. initiated a voluntary recall of
all vials of Sandoz and Parenta brand Methotrexate 50mg/2mL & 250mg/10mL Injection.
The recall is due to small glass flakes detected in a limited number of vials in four lots.
The flakes are the result of delamination of the glass used to manufacture the vials
of the two dosage presentations. Injection of the drug from the affected lots
could lead to serious adverse events in areas where the particles lodge.
Sandoz is advising to immediately discontinue use of this product and to contact your
healthcare provider if you experience any problems that may be related to the use
of this product.
If you currently have Methotrexate 50mg/2mL & 250mg/10mL vials you can arrange for
return and reimbursement through GENCO Pharmaceutical Services, the returns vendor
for Sandoz, by calling the dedicated Methotrexate Recall Hotline or by sending a
message to the recall e-mail address listed below.
Operators are available 24 hours a day, seven days a week to provide assistance.
Source
Contact
Methotrexate Recall Hotline
1-888-896-4565
Methotrexate Recall E-mail Address:
Sandoz.methotrexaterecall@gencopharma.com
The lot numbers and information regarding this recall can also be found at
www.us.sandoz.com.
Thank you for taking the time to review this information.
If you have any questions or concerns regarding the above information please contact the AultCare Service Center at 330-363-6360 or 1-800-344-8858.
or the Aultra Service Center at 330-363-2050 or 1-855-270-8497.