Sandoz and Novartis Recall Prescriptions Drugs, Packaging Fails to Federal Requirements
The Consumer Product Safety Commission (CPSC) has announced the recall of about 74,000 units of drug packages because of a failure to meet closure requirements for child safety.
About the Recalled Drugs
Blister packages of prescription drugs manufactured by Sandoz and Novartis have been recalled. These packages contain between three and ten tablets.
There has been one reported incident of a child ingesting haloperidol from a blister package.
The issue can be remedied by immediately storing the blistering packages out of reach of children. Contents can be consumed after placing in secure area.
Drugs Included in the Recall
74,000 units from Novartis and Sandoz have been recalled.
The following units were manufactured with Novartis:
| 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
|
Dec 2019
|
| Zofran ODT® | 0078-0680-61
0078-0680-19 |
8 mg | 30 count: 3 cards with 10 tablets each | 1641546
|
Oct 2019
|
| Entresto® (sacubitril/valsartan) | 0078-0659-61
0078-0659-35 |
24 mg/ 26 mg | 100 count: 10 cards with 10 tablets each | FX000005
FX000004 FX000003 F0010 F0009 F0007 |
Apr 2020
Apr 2020 Sep 2019 Nov 2018 Aug 2018 Jul 2018 |
| Entresto® (sacubitril/valsartan) | 0078-0777-61
0078-0777-35 |
49 mg/ 51 mg | 100 count: 10 cards with 10 tablets each | FX000001
F0006 F0005 F0004 |
Dec 2019
Oct 2019 Aug 2019 Oct 2018 |
| Entresto® (sacubitril/valsartan) | 0078-0696-61
0078-0696-35 |
97 mg/ 103 mg | 100 count: 10 cards with 10 tablets each | FX000002
F0007 F0006 F0005 F0004 |
Mar 2020
Feb 2020 Dec 2019 Dec 2018 Oct 2018 |
The following unites were manufactured with Sandoz:
| Recalled Sandoz Prescription Drugs | Tablet Strength | NDC Numbers | Carton Configuration |
| Azithromycin Tablets | 250 mg | 0781-5776-06
0781-5776-69 |
50 count: 5 cards with 10 tablets each |
| Donepezil ODT Tablets | 5 mg | 0781-5276-06
0781-5276-64 |
30 count: 3 cards with 10 tablets each |
| Donepezil ODT Tablets | 10 mg | 0781-5277-06
0781-5277-64 |
30 count: 3 cards with 10 tablets each |
| Haloperidol Tablets | 0.5 mg | 0781-1391-13 | 100 count: 10 cards with 10 tablets each |
| Haloperidol Tablets | 1 mg | 0781-1392-13 | 100 count: 10 cards with 10 tablets each |
| Haloperidol Tablets | 2 mg | 0781-1393-13 | 100 count: 10 cards with 10 tablets each |
| Haloperidol Tablets | 5 mg | 0781-1396-13 | 100 count: 10 cards with 10 tablets each |
| Haloperidol Tablets | 10 mg | 0781-1397-13 | 100 count: 10 cards with 10 tablets each |
| Imipramine HCl Tablets | 25 mg | 0781-1764-13 | 100 count: 10 cards with 10 tablets each |
| Imipramine HCl Tablets | 50 mg | 0781-1766-13 | 100 count: 10 cards with 10 tablets each |
| Isosorbide Dinitrate (ISDN) Tablets | 10 mg | 0781-1556-13 | 100 count: 10 cards with 10 tablets each |
| Isosorbide Dinitrate (ISDN) Tablets | 20 mg | 0781-1695-13 | 100 count: 10 cards with 10 tablets each |
| Naratriptan Tablets | 2.5 mg | 0781-5527-06
0781-5527-37 |
9 count: 1 card with 9 tablets |
| Ondansetron Tablets | 8 mg | 0781-1681-33 | 3 count: 1 card with 3 tablets |
| Ondansetron ODT | 4 mg | 0781-5238-06
0781-5238-64 |
30 count: 3 cards with 10 tablets each |
| Ondansetron ODT | 8 mg | 0781-5239-06
0781-5239-64 |
30 count: 3 cards with 10 tablets each |
| Ondansetron ODT | 8 mg | 0781-5239-06
0781-5239-80 |
10 count: 1 card with 10 tablets |
| Perphenazine Tablets | 2 mg | 0781-1046-13 | 100 count: 10 cards with 10 tablets each |
| Perphenazine Tablets | 4 mg | 0781-1047-13 | 100 count: 10 cards with 10 tablets each |
| Perphenazine Tablets | 8 mg | 0781-1048-13 | 100 count: 10 cards with 10 tablets each |
| Risperidone ODT | 0.5 mg | 0781-5310-06
0781-5310-08 |
28 count: 7 cards with 4 tablets each |
| Risperidone ODT | 1 mg | 0781-5311-06
0781-5311-08 |
28 count: 7 cards with 4 tablets each |
| Risperidone ODT | 2 mg | 0781-5312-06
0781-5312-08 |
28 count: 7 cards with 4 tablets each |
| Risperidone ODT | 3 mg | 0781-5313-06
0781-5313-08 |
28 count: 7 cards with 4 tablets each |
| Risperidone ODT | 4 mg | 0781-5314-06
0781-5314-08 |
28 count: 7 cards with 4 tablets each |
Contact an Experienced Liability Attorney
It is a parent’s worst nightmare to find their child has ingested a drug from which they should be protected. If the unthinkable occurs to your child, you need an experienced defective product lawyer to represent you and your child. At Thomas J. Henry, we will fight to get the compensation your child deserves for their injuries and to bring justice to negligent manufacturers. Our firm has represented children from across the United States who have been the victims of negligent pharmaceutical companies.
Our firm has offices in Corpus Christi, San Antonio, and Houston, serving clients across Texas and nationwide. Contact our team of attorneys to receive a free case review. We’re available 24/7, nights and weekends.
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