Pharmacy Innovations Apomorphine Injectable Recalled for Sterility Assurance Failure
Pharmacy Innovations is recalling Apomorphine HCL 2MG/ML injectable vials nationwide due to lack of sterility assurance. FDA inspection found insanitary conditions at the manufacturing 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: FDA Class II recall. Lack of sterility assurance in an injectable is a risk-of-harm condition. The recall is based on insanitary facility conditions identified during FDA inspection, with no illnesses or injuries reported to date.
Plain-English summary
Pharmacy Innovations is recalling Apomorphine HCL 2MG/ML (10 mL vial) injectable, a prescription medication, due to failure to ensure sterility. The product was distributed nationwide in the USA and carries lot code t20221108@46.
During an FDA inspection of the manufacturing facility at 2936 W 17th St., Erie, PA, insanitary conditions were identified that compromised the sterility assurance of the product.
Patients who have received this medication should contact their healthcare provider immediately if they have concerns about their use. Healthcare providers and pharmacies should not dispense this product and should quarantine any remaining stock.
The recalled product
- Product
- Apomorphine HCL 2MG/ML (10ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Prescription 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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