Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Inje
Summary
The FDA issued a Class I for Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automa by Sandoz Inc. Reason: Temperature Abuse; temperature excursion during shipping.
Details
Source
Drug Recall
External ID
D-0286-2022
Action Date
2021-12-08
Status
Completed
Category
drug
Product Description
Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only; 0.4 mL Syringes, Manufactured for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-02; Carton (10 x 0.4 mL Syringes), Manufactured by Shenzhen Techdow Pharmaceutical Co., Ltd. Shenzhen City, Guangdong Province 518057, China for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-64
Lot/Code Info: Lot #SAB06761A, exp 04/2023
Quantity Affected: 45,036 cartons
Reason for Recall
Temperature Abuse; temperature excursion during shipping
Distribution
Nationwide in the US
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-17
Company
Princeton, NJ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 18 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Sandoz Inc has 19 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Sandoz Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Sandoz Inc have FDA actions?
Sandoz Inc has 19 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0286-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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