Clinical Specialties Compounding Pharmacy Recalls Injection Vehicle Due to Sterility Concerns
Clinical Specialties Compounding Pharmacy is recalling 120 ml injection vehicles 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 injection vehicle.
Plain-English summary
Clinical Specialties Compounding Pharmacy, located in Augusta, Georgia, is recalling 120 ml injection vehicles. The recall is being conducted due to FDA inspection findings that raised concerns regarding the quality control processes and the assurance of sterility for the product.
The affected product is identified by lot number CABCCHBB:59 with an expiration date of 5/26/2013. 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
- Injection vehicle, 120 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 (2)
- Lot number CABCCHBB:59
- Exp date: 5/26/2013.
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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