Fresenius Kabi Recalls Heparin Sodium Injection Due to Subpotency
Fresenius Kabi is recalling Heparin Sodium Injection vials because they may contain less active ingredient than labeled.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, which corresponds to a Severe severity score (4) according to the rubric, as it involves a significant health risk.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 161,650 vials of Heparin Sodium Injection, USP 10,000 USP units per 10 mL. The product is a prescription-only, multi-dose vial intended for intravenous or subcutaneous use. The recall is limited to Lot Number 6004137, which has an expiration date of 06/2014.
The recall was initiated because the product is subpotent at the 18-month time point. This means the medication may not contain the full amount of active ingredient stated on the label. The affected product was distributed nationwide.
Healthcare providers and patients should stop using the affected lot and contact their pharmacist or the manufacturer for a replacement or refund. Consumers should not use the recalled product and should return it to the pharmacy where it was purchased.
The recalled product
- Product
- HEPARIN SODIUM (HEPARIN SODIUM)
- Brand
- HEPARIN SODIUM
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Anticoagulant
- Hazard
- Affected units
- 161,650
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 Number: 6004137
- Expiration date: 06/2014
UPCs (3)
- 0363323276010
- 0363323047016
- 0363323543020
Distribution
Distributed nationwide across the United States.
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