Health Innovations Pharmacy Recalls Promethazine Gel Due to Sterility Concerns
Health Innovations Pharmacy is recalling Promethazine 25 mg/0.5 mL Gel because inspection observations indicate a lack of assurance of 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 3/5 (High).
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 pharmaceutical product, which fits the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Health Innovations Pharmacy, Inc. is recalling Promethazine 25 mg/0.5 mL Gel. The recall was initiated due to recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
The source text indicates that the lack of assurance of sterility and stability data does not support the product's expiry. The recall covers all lots of the product. Distribution is limited to North Carolina.
Consumers should stop using the recalled product and contact Health Innovations Pharmacy at (910) 246-5155 for further instructions.
The recalled product
- Product
- Promethazine 25 mg/0.5 mLGel, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
- Manufacturer
- Health Innovations Pharmacy, Inc
- Category
- Drug — Pharmaceutical Gel
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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