Health Innovations Pharmacy Recalls Leucovorin Suspension Due to Sterility Concerns
Health Innovations Pharmacy is recalling Leucovorin 1 mg/1 mL Suspension due to lack of assurance of sterility and stability data. The recall is limited to North Carolina.
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, and the hazard involves a risk to sterility in a pharmaceutical product, which aligns with the 'Severe' criteria for significant injury risk or structural/quality defects in regulated products.
Plain-English summary
Health Innovations Pharmacy, Inc. is recalling Leucovorin 1 mg/1 mL Suspension. The recall was initiated because recent inspection observations associated with certain quality control procedures present a risk to sterility and quality assurance. Specifically, the lack of assurance of sterility and stability data does not support the product's expiry.
The recall affects all lots of the product. Distribution was limited to North Carolina. No specific illness or injury counts are reported in the source text.
Consumers should stop using the product and contact Health Innovations Pharmacy at (910) 246-5155 for further instructions.
The recalled product
- Product
- Leucovorin 1 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
- Manufacturer
- Health Innovations Pharmacy, Inc
- Category
- Drug — Pharmaceutical
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 (1)
- All lots
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 65 recalled by Health Innovations Pharmacy, Inc 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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