June 10, 2015, AstraZeneca voluntarily recalled Nexium (esomeprazole magnesium) delayed release 20mg capsules. The Class II recall was prompted as a result of a retail pharmacist finding Seroquel (atypical antipsychotic quetiapine fumarate) in an unopened bottle of what should have been Nexium.
The recalled bottles are labeled Lot #FC0064 with an expiration date of May 2017. This lot contains 34,524 bottles of Nexium being recalled.
For those members that have this product, it is suggested that they contact their pharmacy.
For those members who use mail order, Benecard Central Fill has not dispensed any recalled lots of Nexium.
No adverse health reactions have been associated with this recall. If you have any questions about this recall please contact your local retail pharmacist or speak to your doctor.
Adverse events that may be related to the use of this product may also be reported to the United States Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:
Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail the form to: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
On October 26, 2015 Auvi‑Q (epinephrine injection, USP) was voluntarily recalled by Sanofi due to potential device malfunction. The products have been found to potentially have inaccurate dosage delivery. This recall includes lot numbers 2299596 through 3037230, with expiration dates between March 2016 and December 2016.
Auvi‑Q is used to treat life‑threatening allergic reactions (anaphylaxis) in people who are at risk for or have a history of these reactions. If a patient experiencing a serious allergic reaction (i.e. anaphylaxis) does not receive the intended dose, there could be significant health consequences, including death because anaphylaxis is a potentially life‑threatening condition.
If you have questions about this recall you can go to the www.auvi-q.com website or call 1-866-726-6340 for information on how to return your Auvi-Q devices. Sanofi will provide reimbursement for out-of-pocket costs incurred for the purchase of new epinephrine auto-injectors with proof of purchase.
You should also contact your prescriber for a new prescription for an alternative epinephrine auto‑injector.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
July 7, 2015, The U.S. Food and Drug Administration announced a recall of Lutera (ethinyl estradiol/levonorgestrel) manufactured by Watson/Actavis. The Class III recall was prompted only as a result of incorrect or missing package inserts and no adverse health reactions have been associated with this recall.
The voluntary recall of this birth control impacts 511,283 boxes from the following lots:
KPPY – Expiration date of June 2015
NBXD, NBXF – Expiration date of October 2016
NBXG – Expiration date of September 2015
NKZS – Expiration date of November 2015
NMPT, NNXB, NNWG – Expiration date of January 2016
NMPV, NVWN, NVWP – Expiration date of February 2016
NMTP, NNXC – Expiration date of March 2016
NMWC, NNXH – Expiration date of April 2016
PFHT, PFHW, PFHX – Expiration date of June 2016
PKHH, PKHN, PKHS, PKHT, PPGG, PPGH, PVSZ – Expiration date of August 2016
PYDX – Expiration date of September 2016
For those members that have this product or any questions about the recall, it is suggested that they contact their pharmacy.
Par Pharmaceutical Companies, Inc. announced that the US Food and Drug Administration (FDA) approved the AB-rated generic version of Exforge (amlodipine/valsartan). Brand Exforge is manufactured by Novartis. Exforge is used for the treatment of high blood pressure.
The generic of Exforge will be available in all current dosage strengths including 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320 mg tablets. Par Pharmaceutical Companies, Inc. was also granted 180 days exclusivity before any other new generics can be approved by the FDA. According to IMS health, Exforge saw annual sales of approximately $422 million.
June 24, 2015, The U.S. Food and Drug Administration (FDA) issued a warning to patients and their prescribers regarding skin color loss as a result of the Daytrana Patch (methylphenidate transdermal system). A new warning label is now required by the FDA to inform patients about chemical leukoderma, which is a skin condition that may be caused by this medication.
The Daytrana Patch is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), to increase attention and decrease restlessness in children and adolescents who are overactive, cannot concentrate for extended periods of time, or are easily distracted and impulsive.
Chemical leukoderma is the discoloring of the skin due to repeated exposure to certain chemicals. The discoloring of the skin is not harmful, however it can cause emotional distress and it is not known whether chemical leukoderma is reversible. The area of skin that may lose color can range in size up to about 8 inches in diameter.
Patients using the Daytrana patch should not stop their medication without first talking to their prescriber and should watch for areas of lighter skin developing, especially under the drug patch. If any indication of skin color loss is noticed, patients should contact their prescriber immediately to report the changes. The FDA recommends that health care professionals consider alternative treatments for patients who experience these skin color changes.