Estradiol Cypionate Injection Recalled Due to Sterility Concerns
Clinical Specialties Compounding Pharmacy is recalling Estradiol Cypionate 5 mg/ml injections due to FDA inspection findings regarding quality control and sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. 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 medication.
Plain-English summary
Clinical Specialties Compounding Pharmacy is recalling specific lots of Estradiol Cypionate 5 mg/ml injections. The recall was initiated following FDA inspection findings that raised concerns regarding the quality control processes and the assurance of sterility for the product.
The affected product is distributed in Florida, Georgia, and South Carolina. The recall covers a total of 95 ml across four specific lots: CABCACBA:20 (expiring 3/31/2013), CABCABBB:22 (expiring 4/30/2013), CABCBJBB:25 (expiring 5/18/2013), and CABDAFAC:79 (expiring 8/4/2013).
Consumers and healthcare providers should stop using the affected lots and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Estradiol Cypionate 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Manufacturer
- Clinical Specialties Compounding Pharmacy
- Category
- Drug — Injectable Steroid
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 CABCACBA:20
- Exp date: 3/31/2013
- Lot number CABCABBB:22
- Exp date: 4/30/2013
- Lot number CABCBJBB:25
- Exp date: 5/18/2013 and Lot number CABDAFAC:79
- Exp date: 8/4/2013.
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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