Apothecary Shoppe Recalls SO-Acetylcysteine Ophthalmic Solution for Sterility Concerns
The Apothecary Shoppe LLC is recalling SO-Acetylcysteine 10% Sterile Ophthalmic Solution due to lack of documentation for environmental monitoring during production.
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: The recall involves a sterile ophthalmic product where sterility assurance is compromised due to documentation gaps. This fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The Apothecary Shoppe LLC is recalling SO-Acetylcysteine 10% Sterile Ophthalmic Solution, a prescription-only ophthalmic product. The recall involves 10 mL bottles with NDC 13452-2774-94. The specific lot number is 05062015@28, with a beyond-use date of 07/05/2015.
The recall was initiated due to a lack of assurance of sterility. This issue arose because there was a lack of documentation confirming proper environmental monitoring during the time the medication was produced. The product was distributed in Oklahoma.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- SO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apothecary Shoppe, Compounding Pharmacy, Tulsa, OK 74135, NDC 13452-2774-94
- Manufacturer
- The Apothecary Shoppe LLC
- Category
- Drug — Ophthalmic Solution
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 (2)
- Lot #: 05062015@28
- BUD 07/05/2015
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 28 recalled by The Apothecary Shoppe LLC 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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