Clinical Specialties Compounding Pharmacy Recalls Estradiol Valerate Due to Sterility Concerns
Clinical Specialties Compounding Pharmacy is recalling Estradiol Valerate 30 mg/ml due to FDA inspection findings regarding quality control and lack of assurance of sterility.
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 severity score under the rubric, particularly given the risk of sterility failure in a pharmaceutical product.
Plain-English summary
Clinical Specialties Compounding Pharmacy is recalling Estradiol Valerate 30 mg/ml, a 18ml product, due to concerns regarding quality control processes. The recall was initiated following FDA inspection findings that resulted in a lack of assurance of sterility for the product.
The affected product is distributed in Florida, Georgia, and South Carolina. The specific lots involved are Lot number CABCBFBB:12 with an expiration date of 5/14/2013, and Lot number CABDAIAD:28 with an expiration date of 9/4/2013.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Estradiol Valerate 30 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Manufacturer
- Clinical Specialties Compounding Pharmacy
- Affected units
- 18
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 (3)
- Lot number CABCBFBB:12
- Exp date: 5/14/2013 and Lot number CABDAIAD:28
- Exp date: 9/4/2013.
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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