Health Innovations Pharmacy Recalls Sildenafil Suspension Due to Sterility Concerns
Health Innovations Pharmacy is recalling Sildenafil 10 mg/1 mL Suspension because inspection observations 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 involves a risk to sterility and quality assurance for a drug product, which fits 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 Sildenafil 10 mg/1 mL Suspension. The recall was initiated 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 supporting the product's expiry.
The recall affects all lots of the product. The distribution pattern is listed as NC (North Carolina). The source text does not specify the exact number of units recalled or specific dates of distribution.
Consumers should stop using the recalled Sildenafil 10 mg/1 mL Suspension and contact their healthcare provider or the recalling firm for further instructions. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Sildenafil 10 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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