News and Alerts

News and Alerts

This page is your source for pharmacy-related safety alerts, drug recalls, announcements of generic drug releases and other medication-related information.

Drug recall notice for valsartan and valsartan-containing drug products

The U.S. Food and Drug Administration (FDA) initiated a recall of select valsartan and valsartan-containing drug products on July 13, 2018. Throughout its investigation, the FDA has continued to expand the recall to additional National Drug Codes (NDCs) and manufacturers. We recommend you review your patients’ medical records and contact patients for whom you have prescribed valsartan or valsartan-containing products affected by the recall. Inform patients of the possible problem and consider clinically appropriate changes to preferred formulary alternatives. Given the ongoing investigation by the FDA, the need for continuous monitoring of this expanding recall and a possible valsartan drug shortage, please consider switching all patients currently taking valsartan to a preferred formulary alternative.

This recall was initiated due to trace amounts of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer, Zhejiang Huahai Pharmaceutical Co. Ltd., that is used in the manufacture of the subject product. This impurity has been classified as a probable human carcinogen by the International Agency for Research on Cancer (IARC). Since the original announcement, the FDA’s continued investigation has identified additional manufacturers and additional recalls have been issued.

Due to the FDA’s ongoing investigation, refer to the FDA’s website for the most updated list of valsartan products under recall: https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm (link opens in new window).

The FDA continues to evaluate valsartan-containing products and will update the inclusion and exclusion list as more information becomes available.

Information for Humana-covered patients

  • Patients should visit the FDA website or their pharmacy for the latest valsartan drug recall list.
  • Patients should continue taking the recalled medication until they have a replacement product.
  • To determine if a specific product is part of the recall, patients should look at the drug name and company name on the label of their prescription bottles. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medication.
  • Patients should contact their healthcare professionals if their medication is included in this recall to discuss their treatment options.
  • Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Angiotensin II receptor blockers (ARBs) equivalency chart

  • Preferred formulary alternatives:

Recalled medication Preferred alternative
valsartan losartan and irbesartan
valsartan/HCTZ losartan/HCTZ and irbesartan/HCTZ
amlodipine/valsartan

amlodipine/benazepril

amlodipine plus irbesartan

amlodipine plus losartan

amlodipine/valsartan/HCTZ

amlodipine plus losartan/HCTZ

amlodipine plus irbesartan/HCTZ

Generic Approximate dose equivalencies for hypertension⁺
valsartan

40 mg daily or
20 mg twice daily

80 mg daily or
40 mg twice daily
160 mg daily 320 mg daily
irbesartan 75 mg daily 150 mg daily 300 mg daily 300 mg daily
losartan 25 mg daily 50 mg daily or
25 mg twice daily
100 mg daily or
50 mg twice daily
benazepril 5 mg daily 10 mg daily 20 mg daily 40 mg daily

Brand-name and generic Copaxone to be covered effective Sept. 1, 2018

Effective Sept. 1, 2018, Humana will cover both brand-name and generic Copaxone (glatiramer acetate) on its Medicare formularies. Glatopa (glatiramer acetate) will remain not covered on Humana’s Medicare formularies.

Prescribers with questions regarding this change may call the Humana Clinical Pharmacy Review team at 1-800-555-CLIN (1-800-555-2546) Monday through Friday, 8 a.m. to 8 p.m. Eastern time. In Puerto Rico, call 1-866-488-5991, Monday through Friday, 8 a.m. to 8 p.m. Eastern time.

Drug recall notice for Novartis and Sandoz blister packs

We want to alert you to a recall of Novartis and Sandoz blister packs, effective July 5, 2018. We recommend you review your patients’ medical records and contact all patients for whom you have prescribed these medications to warn them of the possible problem.

Novartis and Sandoz Inc. voluntarily recalled the medications after discovering that certain blister card packages distributed in the U.S. do not meet U.S. child-resistant packaging requirements and are not compliant for consumer home use.

This recall is due to the in-home dispensing of some hospital unit dose blister packs intended for institutional use. As a result, Novartis and Sandoz have implemented a corrective action plan at the consumer level for packaging that does not meet U.S. child-resistant packaging requirements. The packaging is not child-resistant, posing a risk of harm if the tablets are swallowed by children.

The recalled Novartis prescription blister packages have “Novartis,” the name of the drug, dosage, National Drug Code (NDC), lot number and expiration date printed on the carton and the blister cards. The recall includes the following:

Recalled Novartis prescription drugs NDC numbers Tablet strength Carton configuration Lot numbers Expiration date
Zofran ODT® 0078-0679-61
0078-0679-19
4 mg 30 count: 3 cards with 10 tablets each 1657088 December 2019
Zofran ODT® 0078-0680-61
0078-0680-19
8 mg 30 count: 3 cards with 10 tablets each 1641546 October 2019
Entresto®
(sacubitril/valsartan)
0078-0659-61
0078-0659-35
24 mg/26 mg 100 count: 10 cards with 10 tablets each FX000005 April 2020
Entresto®
(sacubitril/valsartan)
0078-0659-61
0078-0659-35
24 mg/26 mg 100 count: 10 cards with 10 tablets each FX000004 April 2020
Entresto®
(sacubitril/valsartan)
0078-0659-61
0078-0659-35
24 mg/26 mg 100 count: 10 cards with 10 tablets each FX000003 September 2019
Entresto®
(sacubitril/valsartan)
0078-0659-61
0078-0659-35
24 mg/26 mg 100 count: 10 cards with 10 tablets each F0010 November 2018
Entresto®
(sacubitril/valsartan)
0078-0659-61
0078-0659-35
24 mg/26 mg 100 count: 10 cards with 10 tablets each F0009 August 2018
Entresto®
(sacubitril/valsartan)
0078-0659-61
0078-0659-35
24 mg/26 mg 100 count: 10 cards with 10 tablets each F0007 July 2018
Entresto®
(sacubitril/valsartan)
0078-0777-61
0078-0777-35
49 mg/51 mg 100 count: 10 cards with 10 tablets each FX000001 December 2019
Entresto®
(sacubitril/valsartan)
0078-0777-61
0078-0777-35
49 mg/51 mg 100 count: 10 cards with 10 tablets each F0006 October 2019
Entresto®
(sacubitril/valsartan)
0078-0777-61
0078-0777-35
49 mg/51 mg 100 count: 10 cards with 10 tablets each F0005 August 2019
Entresto®
(sacubitril/valsartan)
0078-0777-61
0078-0777-35
49 mg/51 mg 100 count: 10 cards with 10 tablets each F0004 October 2018
Entresto®
(sacubitril/valsartan)
00780696-61
0078-0777-35
49 mg/51 mg 100 count: 10 cards with 10 tablets each FX000002 March 2020
Entresto®
(sacubitril/valsartan)
00780696-61
0078-0777-35
49 mg/51 mg 100 count: 10 cards with 10 tablets each F0007 February 2020
Entresto®
(sacubitril/valsartan)
00780696-61
0078-0777-35
49 mg/51 mg 100 count: 10 cards with 10 tablets each F0006 December 2019
Entresto®
(sacubitril/valsartan)
00780696-61
0078-0777-35
49 mg/51 mg 100 count: 10 cards with 10 tablets each F0005 December 2018
Entresto®
(sacubitril/valsartan)
00780696-61
0078-0777-35
49 mg/51 mg 100 count: 10 cards with 10 tablets each F0004 October 2018

The recalled Sandoz prescription blister packages have “Sandoz,” the name of the drug, dosage, NDC and lot number printed on the cartons and the blister cards. The recall includes the following:

Recalled Sandoz prescription drugs NDC numbers Tablet strength Carton configuration Lot numbers
Azithromycin tablets 0781-5776-69
0781-5776-06
250 mg 50 count: 5 cards with 10 tables each GZ0406
HS2360
Donepezil ODT tablets 0781-5276-64
0781-5276-06
5 mg 30 count: 3 cards with 10 tablets each GV5941
HP4273
HP7999
Donepezil ODT tablets 0781-5277-64
0781-5277-06
10 mg 30 count: 3 cards with 10 tablets each GT9329
GT9335
GU5010
GV8274
HG1597
HG1602
HG1605
HG1606
HG1608
HG1611
Haloperidol tablets 0781-1391-13 0.5 mg 100 count: 10 cards with 10 tablets each GX3374
GX3375
Haloperidol tablets 0781-1392-13 1 mg 100 count: 10 cards with 10 tablets each GR5658
GY0724
Haloperidol tablets 0781-1393-13 2 mg 100 count: 10 cards with 10 tablets each GY9223
GU9925
Haloperidol tablets 0781-1396-13 5 mg 100 count: 10 cards with 10 tablets each GR5643
GR5656
GR5657
GV8400
GX1357
GX3376
GY0712
GZ3830
Haloperidol tablets 0781-1397-13 10 mg 100 count: 10 cards with 10 tablets each GX1356
Imipramine HCI tablets 0781-1764-13 25 mg 100 count: 10 cards with 10 tablets each GW1756
Imipramine HCI tablets 0781-1766-13 50 mg 100 count: 10 cards with 10 tablets each GP0032
Isosorbide Dinitrate (ISDN) tablets 0781-1556-13 10 mg 100 count: 10 cards with 10 tablets each GU4390
HD9905
HG6793
Isosorbide Dinitrate (ISDN) tablets 0781-1695-13 20 mg 100 count: 10 cards with 10 tablets each GM5533
HA5303
Naratriptan tablets 0781-5527-37
0781-5527-06
2.5 mg 9 count: 1 card with 9 tablets each GW3289
GX9049
HF2172
HN7470
HN7479
Ondansetron tablets 0781-1681-33 8 mg 3 count: 1 card with 3 tablets each HT7375
HC4804
Ondansetron ODT 0781-5238-64
0781-5238-06
4 mg 30 count: 3 cards with 10 tablets each GP6543
GP6544
GP6545
GP6546
GS2458
GS2459
GS2461
GU3539
GU3540
GU3541
GV4347
GV8632
GV8633
GV8634
GV8973
GX0373
GX0374
GX0375
GY5043
GY5044
HB1909
HB1910
HB1911
HB1917
HB1919
HB1920
HC8021
HC8022
HC8023
HC8024
HD8428
HD8486
HE2488
HE2489
HE2490
HE2491
HE2492
HE2495
HG2898
HG2903
HG2904
HG2911
HG2923
HS0822
HS0823
HS0824
HS0825
HS0826
HS0827
HS0828
HS0829
HS0830
Ondansetron ODT 0781-5239-80
0781-5239-06
8 mg 10 count: 1 card with 10 tablets each GY2507
HR2402
Ondansetron ODT 0781-5239-64
0781-5239-06
8 mg 30 count: 3 cards with 10 tablets each GV4339
GV9826
GY2493
GY2494
HB1929
HB1931
HB1934
HB1936
HB1932
HG0609
HG0610
HG0611
HG0613
HG4565
HG4566
HG2413
HG4074
HG4077
HU3696
Perphenazine tablets 0781-1046-13 2 mg 100 count: 10 cards with 10 tablets each GY9180
Perphenazine tablets 0781-1047-13 4 mg 100 count: 10 cards with 10 tablets each GT4308
GY9181
Perphenazine tablets 0781-1048-13 8 mg 100 count: 10 cards with 10 tablets each GZ0885
Risperidone ODT 0781-5310-06
0781-5310-08
0.5 mg 28 count: 7 cards with 4 tablets each GR1259
GR1261
GY7793
GY7795
HB2381
HC5284
HG7339
HL5454
HL6626
Risperidone ODT 0781-5311-06
0781-5311-08
1 mg 28 count: 7 cards with 4 tablets each GM7352
GM7353
GR1268
GX9041
GX9042
GX9044
GX9045
GX9046
GX9047
HC6317
HC6319
HG7900
HG9243
HP4284
HP4285
Risperidone ODT 0781-5312-06
0781-5312-08
2 mg 28 count: 7 cards with 4 tablets each GM9497
GP8079
GX6822
GX6823
GX9039
GX9040
HC6321
HC6322
HG7903
HG8724
HR0481
HR0560
Risperidone ODT 0781-5313-06
0781-5313-08
3 mg 28 count: 7 cards with 4 tablets each GM7344
GM7346
GX6827
HA2356
HC6331
HC6334
HR3893
HR3799
Risperidone ODT 0781-5314-08
0781-5314-06
4 mg 28 count: 7 cards with 4 tablets each GM9483
GY1800
GY1801
GY1802
HB2367
HB2369
HB2380
HR5117
HS0834
HS0835

Information for your patients

  • To secure medications in blister packs in the homes of consumers, Sandoz will provide child-resistant resealable pouches to store the medication.
  • Patients should immediately secure impacted blister card packages and the contents to keep out of the sight and reach of children.
  • Patients should continue to use the medicine as prescribed and call Sandoz for important information on corrective action and to request a secure pouch.
  • Consumer contact information provided by Sandoz: Call toll-free at 1-888-669-6682 from Monday to Friday, 8 a.m. to 8 p.m. and Saturday and Sunday, 9 a.m. to 6 p.m. Eastern time. Or visit online at www.us.sandoz.com (link opens in new window) and click on “Patients & Customers” then “Product Safety Notices,” or at www.pharma.us.novartis.com (link opens in new window) and click on the banner “Novartis recalls select product blister packs.”
  • Products dispensed in bottles are not impacted by this recall.
  • There are no quality or safety issues with the medications for their intended use.

References

  1. Sandoz: https://prod.us.sandoz.com/patients-customers/product-safety-notices (link opens in new window)
  2. Novartis: https://www.pharma.us.novartis.com/recall-zofran-and-entresto-packages (link opens in new window)
  3. Consumer Product Safety Commission: https://www.cpsc.gov/Recalls/2018/sandoz-and-novartis-recall-prescription-drug-blister-packages-due-to-failure-to-meet (link opens in new window)

LI NET 60 Day Supply Notification

Effective February 8, 2018 Medicare’s Limited Income NET program (LI NET) will limit the days supply for prescription drugs to no more than a 60-day dispense per fill. The maximum days supply for the below mentioned scenarios, will remain the same:

  • Hepatitis C drugs- maximum days supply is 30
  • Opioids- maximum days supply is 30
  • Unconfirmed beneficiaries (beneficiaries who have not been deemed eligible for LI NET)-maximum days supply is 34

Opioid Limitation Change Notification

Starting February 1, 2018, Medicare’s Limited Income NET Program (LI NET) will limit opioid prescription pain medications that can be filled at one time to a 30-day supply.

Med-Edit Update Notification

Beginning Jan. 1, 2018, Humana Pharmacy Solutions will make enhancements to the opioid utilization program point-of-sale edits based on the opioid thresholds below. Please note: Patients with cancer or in hospice will not be flagged for this edit.

Nuedexta to require prior authorization effective May 1, 2018

Effective May 1, 2018, Humana will add a prior authorization requirement to Nuedexta (dextromethorphan hydrobomide and quinidine sulfate) on its Medicare formularies.

Prescribers with patients currently taking Nuedexta will not be impacted by this change. Those patients will be able to continue taking the medication until the end of the plan year. On May 1, all patients with new prescriptions must have a prior authorization for Nuedexta for the claim to be covered.

Prescribers with questions regarding this change may call the Humana Clinical Pharmacy Review team at 1-800-555-CLIN (1-800-555-2546) Monday through Friday, 8 a.m. to 8 p.m. Eastern time.

Humana announces changes to 2017 formularies

Beginning Jan. 1, 2017, certain drugs will have new limitations or will require utilization management under the Humana Medicare formularies for the 2017 plan year. These changes could mean higher costs or new requirements for Humana members who use these drugs. Humana encourages the use of generic and cost-effective brand medications whenever possible.

Formulary changes

Below are links to charts that show some commonly used medications that will be impacted by the Humana Medicare formulary changes in 2017 (e.g., prior authorization (PA) requirements, step therapy (ST) modifications and nonformulary (NF) changes). Humana members are asked to talk to their physicians and health care professionals about possible alternatives.

Humana to only cover brand-name Voltaren Gel on its Medicare formularies

Effective immediately, Humana will not cover generic Voltaren gel. Brand-name Voltaren Gel can be filled for members without a prior authorization.

Prescribers with questions regarding this change may call 1-800-555-CLIN (1-800-555-2546), Monday through Friday, 8 a.m. to 8 p.m. Eastern time.

Formulary changes for generic Renvela and generic Crestor

Humana has removed generic Renvela (sevelamer) from its Medicare and commercial formularies. Generic Crestor (rosuvastatin) will not be covered on Humana’s Medicare formularies.

Brand-name Renvela and Crestor will remain on Humana’s formularies.

Prescribers with questions regarding this change may call 1-800-555-CLIN (1-800-555-2546), Monday through Friday, 8 a.m. to 8 p.m. Eastern time.

Humana to remove sevelamer from Medicare formularies in April

Effective April 1, 2016, Humana will remove generic Renvela (sevelamer) from its Medicare formularies. Brand-name Renvela will remain on Humana’s formularies.

Patients currently taking the generic drug sevelamer will not be impacted by this change, and Humana will continue to cover the generic medication for these patients until the end of the plan year.

Prescribers with questions regarding this change may call 1-800-555-CLIN (1-800-555-2546), Monday through Friday, 8 a.m. to 8 p.m. Eastern time.