Health Innovations Pharmacy Recalls Laureth-P 1% Injection Due to Sterility Concerns
Health Innovations Pharmacy is recalling Laureth-P 1% Injection because inspection findings indicate a lack of assurance regarding sterility and stability data.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the agency classification as Class II. According to the severity rubric, FDA Class II recalls are mapped to a score of 4 (Severe), particularly when involving sterility risks in injectable medications which carry significant potential for harm.
Plain-English summary
Health Innovations Pharmacy, Inc. is recalling Laureth-P 1% Injection (Polidocanol). 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 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 affected or the specific dates of distribution.
Consumers and healthcare providers should stop using the recalled product and contact Health Innovations Pharmacy at (910) 246-5155 for further instructions or a refund. The FDA has classified this recall as Class II, meaning there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- Laureth-P 1% Injection (Polidocanol), Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
- Manufacturer
- Health Innovations Pharmacy, Inc
- Category
- Drug — Injectable Medication
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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