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.
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 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.
See all 49 products in this recall →Related recalls
Same manufacturer · Clinical Specialties Compounding Pharmacy
See all →- SevereAvastin Syringes Recalled for Sterility Concerns and Eye Infection Reports
FDA (Drugs) · 2013-09-04
- SevereClinical Specialties Compounding Pharmacy Recalls Test Cyp 250 mg-lidocaine 5 mg/ml
FDA (Drugs) · 2013-07-10
- SevereEstradiol Cypionate Injection Recalled Due to Sterility Concerns
FDA (Drugs) · 2013-07-10
- SevereClinical Specialties Compounding Pharmacy Recalls Test Cyp 200 mg/ml Due to Sterility Concerns
FDA (Drugs) · 2013-07-10
- SevereClinical Specialties Compounding Pharmacy Recalls Test Cyp 100 mg/ml Due to Sterility Concerns
FDA (Drugs) · 2013-07-10
Same hazard · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- SevereEstradiol Valerate Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2016-06-15
- SevereEstradiol Valerate Injectable Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereEstradiol Valerate Injectable Vials Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereEstradiol Valerate Injection Recall Due to Sterility Assurance Failure
FDA (Drugs) · 2021-11-17
- SevereEstradiol Valerate Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2021-11-17
- HighWell Care Compounding Pharmacy Recalls Estradiol Valerate Due to Sterility Concerns
FDA (Drugs) · 2016-06-15