PharMEDium Recalls nICARdipine HCl Injection Due to Sterility Assurance Concerns
PharMEDium Services LLC is recalling 46 lots of nICARdipine HCl injection products because of a lack of sterility assurance.
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 recall is classified as FDA Class II and involves a lack of sterility assurance in an injectable drug, which poses a significant risk of infection or serious injury.
Plain-English summary
PharMEDium Services LLC is recalling 46 lots of nICARdipine HCl (0.1 mg/mL) 1 mg/10mL in 0.9% Sodium Chloride Injection USP. The recall is being conducted because of a lack of sterility assurance for these products.
The affected products are distributed nationwide in the US. The specific lot code identified in the recall is 193540006D, with an expiration date of 3/22/2020. The total quantity involved is 80 units.
Healthcare providers and consumers should stop using the affected nICARdipine HCl injection products and contact PharMEDium Services LLC or their healthcare provider for further instructions.
The recalled product
- Product
- nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 10 ml in a 20mL syringe, Rx Only, PharMEDium Services LLC 12620 W. Airport Boulevard #130 Sugar Land, TX 77470. NDC 71019-206-01
- Manufacturer
- PharMEDium Services, LLC
- Category
- Drug — Injectable
- Affected units
- 80
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)
- 193540006D
- Exp 3/22/2020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by PharMEDium Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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