Estradiol Vaginal Cream Recalled for Sterility and Stability Concerns
Health Innovations Pharmacy is recalling Estradiol 0.01% Vaginal Cream 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, and the source text explicitly states that the quality control issues present a risk to sterility, which aligns with the rubric criteria for Severe severity involving significant risk factors.
Plain-English summary
Health Innovations Pharmacy, Inc. is recalling Estradiol 0.01% Vaginal Cream. The recall was initiated following recent inspection observations that identified issues with certain quality control procedures.
The FDA determined that the lack of assurance of sterility and stability data does not support the product's expiry date. These quality control deficiencies present a risk to the sterility and overall quality assurance of the medication.
The recall includes all lots of the product. Distribution was limited to North Carolina. Consumers should stop using the product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Estradiol 0.01% Vaginal Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
- Manufacturer
- Health Innovations Pharmacy, Inc
- Category
- Drug — Topical Steroid/Hormone
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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