Injectable ophthalmic drug recalled for sterility assurance failure
FDA is recalling BSS Plus/Lidocaine Opth 1% injectable syringes manufactured by Pharmacy Innovations due to lack of sterility assurance found during a facility inspection.
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 classified this as Class II. The hazard represents a risk of harm in an injectable drug product where sterility is critical, but no illnesses or injuries are reported in the source text.
Plain-English summary
The FDA is recalling BSS Plus/Lidocaine Opth 1% (1 mL syringe) Injectable, a prescription medication manufactured by Pharmacy Innovations in Erie, Pennsylvania. The product has been distributed nationwide in the United States.
The recall is due to lack of assurance of sterility. An FDA inspection of the manufacturing facility revealed insanitary conditions.
Patients and healthcare providers who have this product should not use it and should consult their healthcare provider regarding the recall.
The recalled product
- Product
- BSS Plus/Lidocaine Opth 1% (1ML syringe) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Ophthalmic Injectable
- Hazard
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)
- t20221004@47
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.
See all 59 products in this recall →Related recalls
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