Class II · Moderate risk Ongoing
Enoxaparin Sodium Injection
Reason Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Enoxaparin Sodium Injection
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Temperature Abuse; temperature excursion during shipping
What was recalled
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
- Recalling firm
- Sandoz Inc
- NDC code
- 00781-3246-02
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0286-2022
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Enoxaparin recalls
See all
Class II · Moderate risk Terminated
Enoxaparin Sodium Injection
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated
Enoxaparin Dofium Injrvyion
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class I · High risk Ongoing
Enoxaparin Sodium Injection
Reason Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding to 120 mg/0.8mL strength)
Class I · High risk Ongoing
Enoxaparin Sodium Injection
Reason Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength)
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