Clinical Specialties Compounding Pharmacy Recalls Test Cyp 25 mg-e(2) Blend
Clinical Specialties Compounding Pharmacy is recalling Test Cyp 25 mg-e(2) blend 12 mg/ml due to FDA inspection findings regarding quality control and lack of assurance of sterility.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in a drug product, which poses a risk of harm without reported illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Clinical Specialties Compounding Pharmacy is recalling Test Cyp 25 mg-e(2) blend 12 mg/ml, 8ml vials. The recall was initiated following FDA inspection findings that raised concerns regarding the quality control processes used during manufacturing.
The specific product affected is identified by Lot number CABCCHBB:03 with an expiration date of 5/26/2013. The product was distributed in Florida, Georgia, and South Carolina.
The reason for the recall is a lack of assurance of sterility. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Test Cyp 25 mg-e(2) blend 12 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Manufacturer
- Clinical Specialties Compounding Pharmacy
- Hazard
- Affected units
- 8
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:03
- 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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