McKesson Recalls Hydralazine Hydrochloride Injection Due to Temperature Abuse
McKesson Medical Surgical is recalling 98 vials of Hydralazine Hydrochloride Injection because some were stored refrigerated instead of at room temperature.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a storage error (temperature abuse) rather than a contamination or manufacturing defect leading to immediate severe harm.
Plain-English summary
McKesson Medical Surgical Inc. is recalling 98 vials of Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL Single Dose Vial. The product is manufactured by APP Fresenius Kabi USA, LLC and distributed nationwide in the USA. The specific lots affected are #6114311 and #6114717, with an expiration date of 05/18.
The recall was initiated because certain pieces of these lots were inadvertently stored refrigerated rather than at the labeled room temperature recommendation. This temperature abuse may affect the stability or quality of the medication.
Healthcare providers and patients should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, it should be discontinued and returned to McKesson Medical Surgical Inc. for further instructions.
The recalled product
- Product
- HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE HYDROCHLORIDE)
- Brand
- HYDRALAZINE HYDROCHLORIDE
- Manufacturer
- Mckesson Medical Surgical
- Category
- Drug — Injection
- Hazard
- Affected units
- 98
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)
- Lot #s: 6114311
- 6114717
- Exp 05/18
UPCs (1)
- 0363323614003
Distribution
Distributed nationwide across the United States.
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