Testosterone Injection Recalled for Sterility and Stability Concerns
Health Innovations Pharmacy is recalling Testosterone 100 mg/1 mL Injection 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 involves a risk-of-harm product (sterility failure in an injectable drug) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Health Innovations Pharmacy, Inc. is recalling Testosterone 100 mg/1 mL Injection. The recall was initiated because recent inspection observations identified deficiencies in quality control procedures. These deficiencies present a risk to the sterility and quality assurance of the product, as stability data does not support the stated expiry.
The recall covers all lots of the product. Distribution was limited to North Carolina. The source text does not specify the number of units affected or report any illnesses or injuries.
Consumers with this product should contact Health Innovations Pharmacy at (910) 246-5155 for instructions on how to return the product.
The recalled product
- Product
- Testosterone 100 mg/1 mL Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
- Manufacturer
- Health Innovations Pharmacy, Inc
- Category
- Drug — Injectable
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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