FDAClass IRecall started November 17, 2021

Enoxaparin Sodium Injection 40 mg/0.4mL Recall

Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only; 0.4 mL…

What is the FDA recall status?

The FDA record lists the status as Completed. This does not establish that a retained product is safe to consume or use. FDA enforcement data is not a live recall-lifecycle tracker. Check the agency notice or firm for current guidance.

How FDA enforcement data reports status

Why was Enoxaparin Sodium Injection 40 mg/0.4mL recalled?

Temperature Abuse; temperature excursion during shipping

What should I do if I have this product?

Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.

Full 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

Which lot codes, UPCs or models are affected?

Lot #SAB06761A, exp 04/2023

Agency record number
D-0286-2022
Product
Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only; 0.4 mL…
Recalling firm
Sandoz Inc
Quantity
45,036 cartons
Distribution
Nationwide in the US
Recall started
November 17, 2021
Report date
December 8, 2021
Classification
Class I
Status
Completed
Agency
FDA (drug)
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