Pregnenolone 20 mg SR Capsules Recalled for Sterility and Stability Concerns
Health Innovations Pharmacy is recalling all lots of Pregnenolone 20 mg SR Capsules due to quality control issues affecting sterility and stability.
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 is classified as FDA Class II, and the source text explicitly states that the quality control issues present a risk to sterility and quality assurance, which aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Health Innovations Pharmacy, Inc is recalling all lots of Pregnenolone 20 mg SR Capsules. The recall was initiated because recent inspection observations identified deficiencies in certain quality control procedures. These deficiencies present a risk to the sterility and quality assurance of the product, as the available stability data does not support the stated expiry dates.
The recalled product is distributed in North Carolina. Consumers who possess this medication should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Pregnenolone 20 mg SR Capsule, 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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