Estradiol Valerate Injection Recalled Due to Sterility Concerns
Clinical Specialties Compounding Pharmacy is recalling Estradiol Valerate 20 mg/ml injections due to FDA inspection findings regarding quality control and sterility assurance.
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, which corresponds to a Severe severity score under the rubric, particularly given the risk of sterility failure in an injectable medication.
Plain-English summary
Clinical Specialties Compounding Pharmacy is recalling Estradiol Valerate 20 mg/ml injections. The recall is being conducted because FDA inspection findings resulted in concerns regarding quality control processes and the lack of assurance of sterility.
The affected product is distributed in Florida, Georgia, and South Carolina. The specific lots involved are Lot number CABCADBA:96 with an expiration date of 4/1/2013, and Lot number CABCAIBA:31 with an expiration date of 4/6/2013. The total quantity recalled is 17ml.
Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Estradiol Valerate 20 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Manufacturer
- Clinical Specialties Compounding Pharmacy
- Category
- Drug — Injectable
- Affected units
- 17
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 CABCADBA:96
- Exp date: 4/1/2013 and Lot number CABCAIBA:31
- Exp date: 4/6/2013.
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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