Health Innovations Pharmacy Recalls T4/T3 Capsules Due to Sterility Concerns
Health Innovations Pharmacy is recalling T4 66mcg - T3 10mcg SR 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. The hazard involves a lack of assurance of sterility, which is a significant quality defect for a pharmaceutical product, aligning with the 'Severe' criteria for significant risk or structural defects in regulated products.
Plain-English summary
Health Innovations Pharmacy, Inc. is recalling T4 66mcg - T3 10mcg SR Capsules. The recall was initiated following recent inspection observations associated with certain quality control procedures. These observations present a risk to the sterility and quality assurance of the product, specifically regarding the lack of assurance of sterility and stability data supporting the expiry date.
The recall affects all lots of the product. The distribution pattern is listed as NC (North Carolina). Consumers who have this product should stop using it and contact the recalling firm or their healthcare provider for instructions on disposal or replacement.
The recalled product
- Product
- T4 66mcg - T3 10mcg SR Capsule, 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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