Acetylcysteine 20% Solution Recalled Due to Sterility Concerns
Clinical Specialties Compounding Pharmacy is recalling Acetylcysteine 20% solution due to FDA inspection findings regarding quality control and lack of assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of sterility failure in a medical solution.
Plain-English summary
Clinical Specialties Compounding Pharmacy is recalling Acetylcysteine 20% solution, 100 ml bottles. The recall is being conducted due to FDA inspection findings that resulted in concerns regarding quality control processes and a lack of assurance of sterility.
The affected product is identified by Lot number CABCAJBA:76 with an expiration date of 10/4/2013. The product was distributed in Florida, Georgia, and South Carolina.
Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Acetylcysteine 20 % solution, 100 ml bottle, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Manufacturer
- Clinical Specialties Compounding Pharmacy
- Category
- Drug — Compounded Medication
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 number CABCAJBA:76
- Exp date: 10/4/2013
Distribution
Part of a larger recall action
This product is one of 49 recalled by Clinical Specialties Compounding Pharmacy 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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