Clinical Specialties Compounding Pharmacy Recalls Testosterone and Estradiol Injection
Clinical Specialties Compounding Pharmacy is recalling Test cyp 25 mg-estradiol cyp 7 mg/ml injections due to 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 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 and involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection.
Plain-English summary
Clinical Specialties Compounding Pharmacy is recalling 12ml vials of Test cyp 25 mg-estradiol cyp 7 mg/ml. The recall is due to FDA inspection findings that raised concerns regarding quality control processes, specifically a lack of assurance of sterility.
The affected product is identified by Lot number CABCAFBC:67 and has an expiration date of 6/3/2013. The product was distributed in Florida, Georgia, and South Carolina.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions.
The recalled product
- Product
- Test cyp 25 mg-estradiol cyp 7 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Manufacturer
- Clinical Specialties Compounding Pharmacy
- Category
- Drug — Injectable Medication
- Affected units
- 12
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 CABCAFBC:67
- Exp date: 6/3/2013.
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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