Health Innovations Pharmacy Recalls Hydroxyurea Suspension Due to Sterility Concerns
Health Innovations Pharmacy is recalling Hydroxyurea 100 mg/1 mL Suspension because inspection findings indicate a lack of assurance regarding sterility and stability data.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk to sterility and quality assurance without reported illnesses or injuries, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Health Innovations Pharmacy, Inc. is recalling Hydroxyurea 100 mg/1 mL Suspension. The recall is being conducted due to recent inspection observations associated with certain quality control procedures. These observations present a risk to sterility and quality assurance, specifically regarding the lack of assurance of sterility and stability data that supports the product's expiry.
The recall affects all lots of the product. The distribution pattern is listed as NC, indicating the product was distributed in North Carolina. The source text does not specify the number of units recalled or the specific dates of distribution.
Consumers who have this product should contact Health Innovations Pharmacy at (910) 246-5155 or visit their facility at 295 Pinehurst Ave, Southern Pines, NC 28387 for further instructions. The source text does not provide specific instructions for disposal or return, so contacting the recalling firm is the recommended course of action.
The recalled product
- Product
- Hydroxyurea 100 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
- Manufacturer
- Health Innovations Pharmacy, Inc
- Category
- Drug — Antineoplastic
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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