November 2021 FDA Recall Drug by Sandoz Inc
D-0286-2022 - Temperature Abuse; temperature excursion during shipping

This Class I drug recall was voluntarily initiated by Sandoz Inc on November 17, 2021 for the product Drug. The FDA reported the reason for recall as temperature abuse; temperature excursion during shipping. The product was distributed Nationwide and the recall is currently completed.

Recall Number: D-0286-2022

Reason for Recall
Temperature Abuse; temperature excursion during shipping
Initiated
11-17-2021
Reported
12-08-2021
Quantity
45,036 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89033
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sandoz Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the US
Product Description About Product Description
Full technical description of the 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 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

Batch or Lot Expiration Information

Lot# SAB06761A, exp 04/2023