Enoxaparin syringe bags recalled after being labeled with the wrong strength
Sandoz Enoxaparin Sodium Injection bags labeled 80 mg/0.8 mL were found to contain 30 mg/0.3 mL prefilled syringes. 10 bags distributed in Kansas are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; a bag labelled at one strength containing another could lead to the wrong dose of an anticoagulant, and no injuries are reported.
Plain-English summary
Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL in 0.3 mL prefilled syringes, further packaged in bags of five prefilled syringes and available on prescription only, distributed by Sandoz Inc. of Princeton, New Jersey, is being recalled. The outer package carries NDC 55154-3543-5 with lot SAD08033AA and the inner label carries NDC 0781-3238-01 with lot SAF13211A. The recall covers 10 bags distributed in Kansas.
The recall was issued because of a correct labeled product mispack: bags labelled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL. The FDA classified the action as Class II.
Pharmacies holding these lots should quarantine them and follow Sandoz's instructions for return. Patients should confirm the strength printed on the syringe with their pharmacist before use.
The recalled product
- Product
- ENOXAPARIN SODIUM (ENOXAPARIN SODIUM)
- Brand
- ENOXAPARIN SODIUM
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Anticoagulant
- Affected units
- 10
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 (3)
- Outer package - NDC 55154-3543-5
- Lot SAD08033AA Inner label - NDC 0781-3238-01
- Lot SAF13211A
UPCs (4)
- 0055154354059
- 0055154354455
- 0055154354257
- 0055154354158
Distribution
Distributed in 1 state:
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