Clinical Specialties Compounding Pharmacy Recalls Acetylcysteine 10% Solution
Clinical Specialties Compounding Pharmacy is recalling Acetylcysteine 10% 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. According to the rubric, FDA Class II recalls involving significant risks such as lack of sterility assurance in injectable solutions are categorized as Severe (Score 4), particularly when structural or process defects are identified by the agency.
Plain-English summary
Clinical Specialties Compounding Pharmacy is recalling Acetylcysteine 10% Solution, 300ml bottles. The recall was initiated following FDA inspection findings that raised concerns regarding the company's quality control processes. Specifically, there is a lack of assurance of sterility for the affected product.
The affected product is identified by Lot number CABCAFBA:73 with an expiration date of 9/30/2013. The product was distributed in Florida, Georgia, and South Carolina. The agency classification for this recall is Class II.
Consumers and healthcare providers who have this product should stop using it and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Acetylcysteine 10 % Solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Manufacturer
- Clinical Specialties Compounding Pharmacy
- Affected units
- 300
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 CABCAFBA:73
- Exp date: 9/30/2013
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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