Fresenius Kabi Recalls Hydralazine Hydrochloride Injection Due to Incorrect Expiration Date
Fresenius Kabi USA is recalling 93,000 vials of Hydralazine Hydrochloride Injection because the expiration date printed on the secondary packaging is incorrect.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/packaging error.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 93,000 vials of Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL single-dose vial. The product is identified by NDC 63323-614-01, Lot # 6110593, and an expiration date of 11/2016. The recall is due to an incorrect expiration date printed on the tray (secondary packaging), which states "11/06" instead of the correct "11/2016".
The affected product was distributed nationwide. The agency has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
Consumers and healthcare providers should check their inventory for this specific lot and expiration date discrepancy. If found, the product should be returned to the distributor or the manufacturer for credit.
The recalled product
- Product
- HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE HYDROCHLORIDE)
- Brand
- HYDRALAZINE HYDROCHLORIDE
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Injection
- Hazard
- Affected units
- 93,000
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 #: 6110593
- Exp 11/2016
UPCs (1)
- 0363323614003
Distribution
Distributed nationwide across the United States.
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