Clinical Specialties Compounding Pharmacy Recalls Test Cyp 250 mg-lidocaine 5 mg/ml
Clinical Specialties Compounding Pharmacy is recalling Test Cyp 250 mg-lidocaine 5 mg/ml due to lack of assurance of sterility identified during an FDA inspection.
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. According to the rubric, FDA Class II recalls involving significant risks such as sterility issues in injectable drugs are categorized as Severe (Score 4), as they carry a risk of serious injury or death, even if specific hospitalization reports are not detailed in the provided text.
Plain-English summary
Clinical Specialties Compounding Pharmacy is recalling Test Cyp 250 mg-lidocaine 5 mg/ml, a 10ml product. The recall was initiated following FDA inspection findings that raised concerns regarding quality control processes, specifically a lack of assurance of sterility.
The affected products are identified by Lot number CABCCABB:74 with an expiration date of 5/19/2013, and Lot number CABCCABB:31 with an expiration date of 7/29/2013. These products were distributed in Florida, Georgia, and South Carolina.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Test Cyp 250 mg-lidocaine 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Manufacturer
- Clinical Specialties Compounding Pharmacy
- Category
- Drug — Compounded Injectable
- Affected units
- 10
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 CABCCABB:74
- Exp date: 5/19/2013 and Lot number CABCCABB:31 Exp date: 7/29/2013.
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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