Sandoz Enoxaparin Sodium Injection Recalled Due to Temperature Excursion
Sandoz Inc. is recalling 45,036 cartons of Enoxaparin Sodium Injection USP 40 mg/0.4 mL due to temperature abuse during shipping. The affected lot was distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall, which mandates a minimum severity score of 4. Enoxaparin is a critical anticoagulant medication; temperature excursions may compromise efficacy or safety, posing serious health risks to patients dependent on this drug.
Plain-English summary
Sandoz Inc. is recalling Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device (NDC 00781-3246-02 and 00781-3246-64, Lot #SAB06761A, expiration 04/2023) manufactured by Shenzhen Techdow Pharmaceutical Co., Ltd. in China for Sandoz Inc., Princeton, NJ.
The recall was initiated due to a temperature excursion that occurred during shipping. The affected product consists of 45,036 cartons that were distributed nationwide in the United States.
Patients using this medication should consult their healthcare provider or pharmacist immediately to determine if they have received affected units. Consumers and healthcare providers are advised to stop using the recalled product and return it to the dispensing pharmacy.
This is a Class I recall, indicating that the affected product may pose serious health risks.
The recalled product
- 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 T
- Manufacturer
- Sandoz Inc
- Category
- Drug — Injectable Anticoagulant
- Hazard
- temperature-excursion
- product-stability
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #SAB06761A
- exp 04/2023
Distribution
Distributed nationwide across the United States.
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