Agency classClass IIOur severity:High FDA (Drugs)·D-0191-2023·Announced 2023-02-01

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.

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 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.

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 →

Same manufacturer · Pharmacy Innovations

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Same hazard · lack of sterility