Health Innovations Pharmacy Recalls Warfarin Capsules Due to Sterility Concerns
Health Innovations Pharmacy is recalling Warfarin 2.5 ng Lactose Free Capsules due to inspection findings regarding sterility and stability data.
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 rubric specifies that FDA Class II recalls with potential for significant injury or structural defects (implied by sterility risks in pharmaceuticals) align with a Severe rating, particularly when specific injury reports are not explicitly detailed but the defect is significant.
Plain-English summary
Health Innovations Pharmacy, Inc. is recalling Warfarin 2.5 ng Lactose Free Capsules. The recall is being conducted because recent inspection observations associated with certain quality control procedures present a risk to sterility and quality assurance. The source text indicates that a lack of assurance of sterility and stability data does not support the product's expiry.
The recall applies to all lots of the product. The distribution pattern is listed as NC (North Carolina). The source text does not specify the number of units affected or the specific dates of distribution.
Consumers who have purchased this product should contact Health Innovations Pharmacy at (910) 246-5155 for further instructions. The source text does not provide specific consumer action steps beyond the contact information for the recalling firm.
The recalled product
- Product
- Warfarin 2.5 ng Lactose Free Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
- Manufacturer
- Health Innovations Pharmacy, Inc
- Category
- Drug — Anticoagulant
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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