Ketamine 50mg/ml Injectable Vial Recalled for Sterility Concerns
Pharmacy Innovations is recalling Ketamine 50mg/ml injectable vials nationwide due to insanitary facility conditions that compromised sterility assurance.
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: Per the severity rubric, this recall qualifies as High because it involves a risk-of-harm product (an injectable with compromised sterility assurance) where injury has not yet been reported. Sterility failure in parenteral drugs poses significant potential for serious infection-related harm.
Plain-English summary
Pharmacy Innovations is recalling Ketamine 50mg/ml (10ml vial) Injectable (Rx only) nationwide due to a lack of assurance of sterility. FDA inspection revealed insanitary conditions at the manufacturing facility in Erie, PA that could compromise the sterility of the product.
The recalled product is identified by lot code t20221031@55. The product was distributed nationwide in the USA. Individuals currently using this medication should consult with their healthcare provider regarding their treatment.
The recalled product
- Product
- KETAMINE 50MG/ML (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Injectable Drug
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)
- t20221031@55
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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