Novartis and Sandoz blister packs

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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.

Recalled Novartis prescription drugs

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:

Zofran ODT®

Carton configuration: 30 count—3 cards with 10 tablets each

NDC numbers Tablet strength Lot number Expiration date 0078-0679-61, 0078-0679-19 4 mg 1657088 December 2019 0078-0680-61, 0078-0680-19 8 mg 1641546 October 2019

Entresto® (sacubitril/valsartan)

Carton configuration: 100 count—10 cards with 10 tablets each

NDC numbers Tablet strength Lot number Expiration date 0078-0659-61, 0078-0659-35 24 mg/26 mg FX000005 April 2020 0078-0659-61, 0078-0659-35 24 mg/26 mg FX000004 April 2020 0078-0659-61, 0078-0659-35 24 mg/26 mg FX000003 September 2019 0078-0659-61, 0078-0659-35 24 mg/26 mg F0010 November 2018 0078-0659-61, 0078-0659-35 24 mg/26 mg F0009 August 2018 0078-0659-61, 0078-0659-35 24 mg/26 mg F0007 July 2018 0078-0777-61, 0078-0777-35 49 mg/51 mg FX000001 December 2019 0078-0777-61, 0078-0777-35 49 mg/51 mg F0006 October 2019 0078-0777-61, 0078-0777-35 49 mg/51 mg F0005 August 2019 0078-0777-61, 0078-0777-35 49 mg/51 mg F0004 October 2018 00780696-61, 0078-0777-35 49 mg/51 mg FX000002 March 2020 00780696-61, 0078-0777-35 49 mg/51 mg F0007 February 2020 00780696-61, 0078-0777-35 49 mg/51 mg F0006 December 2019 00780696-61, 0078-0777-35 49 mg/51 mg F0005 December 2018 00780696-61, 0078-0777-35 49 mg/51 mg F0004 October 2018

Recalled Sandoz prescription drugs

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:

Azithromycin tablets

NDC numbers: 0781-5776-69, 0781-5776-06
Carton configuration: 50 count—5 cards with 10 tablets each

Tablet strength Lot number 250 mg GZ0406, HS2360

Donepezil ODT tablets

Carton configuration: 30 count—3 cards with 10 tablets each

NDC numbers Tablet strength Lot number 0781-5276-64, 0781-5276-06 5 mg GV5941, HP4273, HP7999 0781-5277-64, 0781-5277-06 10 mg GT9329, GT9335, GU5010, GV8274, HG1597, HG1602, HG1605, HG1606, HG1608, HG1611

Haloperidol tablets

Carton configuration: 100 count—10 cards with 10 tablets each

NDC numbers Tablet strength Lot number 0781-1391-13 0.5 mg GX3374, GX3375 0781-1392-13 1 mg GR5658, GY0724 0781-1393-13 2 mg GY9223, GU9925 0781-1396-13 5 mg GR5643, GR5656, GR5657, GV8400, GX1357, GX3376, GY0712, GZ3830 0781-1397-13 10 mg GX1356

Imipramine Hcl tablets

Carton configuration: 100 count—10 cards with 10 tablets each

NDC numbers Tablet strength Lot number 0781-1764-13 25 mg GW1756 0781-1766-13 50 mg GP0032

Isosorbide dinitrate (ISDN) tablets

Carton configuration: 100 count—10 cards with 10 tablets each

NDC numbers Tablet strength Lot number 0781-1556-13 10 mg GU4390, HD9905, HG6793 0781-1695-13 20 mg GM5533, HA5303

Naratriptan tablets

NDC numbers:  0781-5527-37, 0781-5527-06
Carton configuration: 9 count—1 card with 9 tablets each

Tablet strength Lot number 2.5 mg GW3289, GX9049, HF2172, HN7470, HN7479

Ondansetron tablets

NDC number: 0781-1681-33
Carton configuration: 3 count—1 card with 3 tablets each

Tablet strength Lot number 8 mg HT7375, HC4804

Ondansetron ODT

NDC numbers Tablet strength Carton configuration Lot number 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 0781-5239-80, 0781-5239-06 8 mg 10 count—1 card with 10 tablets each GY2507, HR2402 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

Carton configuration: 100 count—10 cards with 10 tablets each

NDC numbers Tablet strength Lot number 0781-1046-13 2 mg GY9180 0781-1047-13 4 mg GT4308, GY9181 0781-1048-13 8 mg GZ0885

Risperidone ODT

Carton configuration: 28 count—7 cards with 4 tablets each

NDC numbers Tablet strength Lot number 0781-5310-06, 0781-5310-08 0.5 mg GR1259, GR1261, GY7793, GY7795, HB2381, HC5284, HG7339, HL5454, HL6626 0781-5311-06, 0781-5311-08 1 mg GM7352, GM7353, GR1268, GX9041, GX9042, GX9044, GX9045, GX9046, GX9047, HC6317, HC6319, HG7900, HG9243, HP4284, HP4285 0781-5312-06, 0781-5312-08 2 mg GM9497, GP8079, GX6822, GX6823, GX9039, GX9040, HC6321, HC6322, HG7903, HG8724, HR0481, HR0560 0781-5313-06, 0781-5313-08 3 mg GM7344, GM7346, GX6827, HA2356, HC6331, HC6334, HR3893, HR3799 0781-5314-08, 0781-5314-06 4 mg 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 Sandoz website , opens new window and select "Patients & Customers" then "Product Safety Notices," or at Novartis website , opens new window and select 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.

Sources

  1. Sandoz website , opens new window

  2. Novartis website , opens new window

  3. Consumer Product Safety Commission website , opens new window