Injectable NADH Recalled for Sterility Concerns at Manufacturing Facility
Pharmacy Innovations is recalling NADH 10MG/ML injectable vials distributed nationwide due to lack of assurance of sterility. FDA inspection revealed insanitary conditions at the facility.
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: This is a Class II FDA recall of an injectable product where sterility assurance has been compromised due to identified insanitary manufacturing conditions. No illnesses or injuries have been reported, but injectable products with potential sterility failures represent a risk-of-harm situation that warrants a High severity rating.
Plain-English summary
Pharmacy Innovations is recalling NADH 10MG/ML (10ML VIAL) INJECTABLE, Rx Only, due to a lack of assurance of sterility. During an FDA inspection of the manufacturing facility located at 2936 W 17th St., Erie, PA, insanitary conditions were identified that could compromise product sterility.
The affected product was distributed nationwide. The recall applies to all units with code t20221108@46.
This is a serious concern because injectable products require strict sterility standards to prevent infection and other complications. Healthcare providers and patients who have received this product should contact their healthcare provider if they have any concerns.
The recalled product
- Product
- NADH 10MG/ML (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- 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)
- t20221108@46
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 59 recalled by Pharmacy Innovations 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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