Nortriptyline Suspension Recalled for Sterility and Stability Concerns
Health Innovations Pharmacy is recalling Nortriptyline 10 mg/5 mL Suspension 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 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/quality assurance) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Health Innovations Pharmacy, Inc. is recalling one prescription of Nortriptyline 10 mg/5 mL Suspension. The recall is limited to the state of North Carolina.
The recall was initiated due to a lack of assurance of sterility and stability data that supports the product's expiry date. Recent inspection observations identified issues with certain quality control procedures that present a risk to sterility and quality assurance.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Nortriptyline 10 mg/5 mL Susp, 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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