Class II · Moderate risk
Acetylcysteine Solution
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
SO-Acetylcysteine 10% Sterile Ophthalmic Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
SO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apothecary Shoppe, Compounding Pharmacy, Tulsa, OK 74135, NDC 13452-2774-94
Affected NDC
13452-2774-94
Compare with the code on your package — it is the most precise check available.
Drug: Acetylcysteine Category: Eye Drops & Ophthalmic
- Recalling firm
- The Apothecary Shoppe LLC
- NDC code
- 13452-2774-94
- Origin
- OK, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1312-2015 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Acetylcysteine recalls
See all
Class II · Moderate risk
Acetylcysteine Solution
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Class II · Moderate risk
Acetylcysteine 10% Ophthalmic Solution
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
ACETYLCYSTEINE OPTH 5% Solution
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
ACETYLCYSTEINE OPTH 10% Solution
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Other recalls by The Apothecary Shoppe LLC
All 2015 recalls
Class II · Moderate risk
Tri-Mix 18/1/10
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
Class II · Moderate risk
Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
Class II · Moderate risk
Methylcobalamin 5000 mcg/mL Injection
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
Class II · Moderate risk
S-Methylcobalamin 5000 mcg/mL Inj.
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
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