Diazepam 5 mg/ml Recalled for Lack of Sterility Assurance
Clinical Specialties Compounding Pharmacy is recalling Diazepam 5 mg/ml due to FDA inspection findings regarding quality control and lack of sterility assurance.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is related to quality control and sterility assurance rather than a confirmed high-risk pathogen or structural defect.
Plain-English summary
Clinical Specialties Compounding Pharmacy is recalling Diazepam 5 mg/ml, a liquid medication, due to concerns regarding quality control processes. The recall was initiated following FDA inspection findings that resulted in a lack of assurance of sterility for the product.
The affected product consists of 222 ml total of Diazepam 5 mg/ml. The specific lots involved are Lot number CABDBGAB:84 with an expiration date of 4/16/2013, and Lot number CABDAIAC:45 with an expiration date of 5/9/2013. The product was distributed in Florida, Georgia, and South Carolina.
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the pharmacy or the recalling firm, Clinical Specialties Compounding Pharmacy, located at 318 Baston Road, Augusta, GA 30907.
The recalled product
- Product
- Diazepam 5 mg/ml, 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 (3)
- Lot number CABDBGAB:84
- Exp date: 4/16/2013 and Lot number CABDAIAC:45
- Exp date: 5/9/2013.
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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