FDA Recalls Acetylcysteine Ophthalmic Solution Due to Sterility Concerns
Pharmacy Innovations is recalling Acetylcysteine 10% Ophthalmic Solution nationwide due to FDA-identified insanitary manufacturing conditions that compromise product sterility. Affected batches include codes t20221011@36 and t20221108@24.
What this means for you
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 with confirmed insanitary manufacturing conditions that undermine sterility assurance. Although no illnesses or adverse events have been reported, ophthalmic solutions administered directly to the eye pose risk of serious infection if non-sterile, fitting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Pharmacy Innovations, located in Erie, Pennsylvania, is recalling Acetylcysteine 10% Ophthalmic Solution distributed nationwide. The affected product is identified by batch codes t20221011@36 and t20221108@24.
The FDA initiated this recall following a facility inspection that identified insanitary conditions at the manufacturing facility. These conditions have resulted in a loss of assurance that the product meets sterility requirements.
This recall affects any patients who may have received the affected batches. Patients and healthcare providers should contact the FDA or Pharmacy Innovations for information regarding the return of affected product and appropriate next steps.
Healthcare providers and pharmacies should immediately segregate the affected product from dispensing inventory and contact Pharmacy Innovations for return instructions.
The recalled product
- Product
- Acetylcysteine 10% Ophthalmic Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Ophthalmic Solution
- Hazard
- lack-of-sterility
- contamination-risk
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)
- t20221011@36 t20221108@24
Distribution
Distributed nationwide across the United States.
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