FDA Recalls Pilocarpine Ophthalmic Solution Due to Incomplete Stability Studies
Akorn Inc. recalled all lots of Pilocarpine Hydrochloride Ophthalmic Solution 1% nationwide due to CGMP deviations. The firm went out of business and could not complete required stability studies.
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: This is a Class II recall for a prescription ophthalmic medication with unverified long-term stability due to incomplete testing. While no illnesses or injuries have been reported, the product represents a potential risk of harm because its safety and efficacy over its shelf life cannot be assured. This meets the criterion for a High severity recall as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Akorn, Inc. is recalling all lots of Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles distributed nationwide in the USA and Puerto Rico. This is a Class II recall.
The recall was initiated due to current good manufacturing practice (CGMP) deviations. Specifically, the firm went out of business and could no longer continue the stability studies required to verify that the product remains safe and effective throughout its shelf life. Without completion of these stability studies, the product's long-term safety and efficacy cannot be assured.
The recalled product
- Product
- Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- unverified-stability
- cgmp-deviation
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)
- All Lots
Distribution
Distributed nationwide across the United States.
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