Mylan Recalls Subpotent Nicardipine Hydrochloride Injection Vials
Mylan Institutional LLC is recalling specific lots of Nicardipine Hydrochloride Injection because the product failed potency and impurity specifications.
What this means for you
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 III, which indicates the product is unlikely to cause adverse health consequences. The hazard involves subpotency and impurities, which are quality issues but do not meet the criteria for higher severity scores in the absence of reported injuries or specific high-risk pathogen involvement.
Plain-English summary
Mylan Institutional LLC is voluntarily recalling 78,090 vials of Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL), 10 mL single dose vials. The affected product is prescription-only and was manufactured in India for distribution nationwide in the United States.
The recall was initiated because the product was found to be subpotent and failed impurities/degradation specifications. This means the medication may not contain the intended amount of the active ingredient and may contain unacceptable levels of impurities or degradation products.
The affected lots are UW301 and UW302 with an expiration date of 02/15, and lots UW303, UW304, UW305, and UW306 with an expiration date of 04/15. Healthcare providers and patients should check their inventory or prescriptions for these specific lot numbers and expiration dates. If the product is found, it should be returned to the supplier or disposed of according to local regulations. Patients should consult their healthcare provider for alternative treatment options if they have been prescribed this specific medication.
The recalled product
- Product
- Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-224-10
- Manufacturer
- Mylan Institutional LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 78,090
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 (8)
- Lot #: UW301
- UW302
- Exp 02/15
- UW303
- UW304
- UW305
- UW306
- Exp 04/15
Distribution
Distributed nationwide across the United States.
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