Sodium Chloride Recall Due to Sterility Concerns
Clinical Specialties Compounding Pharmacy is recalling Sodium Chloride (23.4%) due to FDA inspection findings regarding quality control and sterility assurance.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 an injectable solution.
Plain-English summary
Clinical Specialties Compounding Pharmacy is recalling specific lots of Sodium Chloride (23.4%) because of concerns regarding quality control processes and the assurance of sterility. The recall was initiated following FDA inspection findings.
The affected product is distributed in Florida, Georgia, and South Carolina. The specific lots involved are CABCCEAJ:09 (expiring 3/23/2013), CABCBFBA:92 (expiring 4/13/2013), CABDAGAC:58 (expiring 8/5/2013), and CABDAEAD:01 (expiring 8/31/2013). The total quantity recalled is 116ml.
Healthcare providers and consumers should stop using the affected lots and contact the recalling firm for further instructions or a refund.
The recalled product
- Product
- Sodium Chloride (23.4%), Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Manufacturer
- Clinical Specialties Compounding Pharmacy
- Category
- Drug — Injectable Solution
- Affected units
- 116
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 (7)
- Lot number CABCCEAJ:09
- Exp date: 3/23/2013
- Lot number CABCBFBA:92
- Exp date: 4/13/2013
- Lot number CABDAGAC:58
- Exp date: 8/5/2013 and Lot number CABDAEAD:01
- Exp date: 8/31/2013.
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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