CLASS II Drug recall · Reported 10 Jul 2013 · FDA Enforcement Report
Estradiol Valerate 20 mg/ml recalled by Clinical Specialties
Clinical Specialties Compounding Pharmacy is recalling Estradiol Valerate 20 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, distributed in Florida, Georgia, South Carolina. The recall was initiated on 20 Mar 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-640-2013
- FDA event ID
- 64661
- Recalling firm
- Clinical Specialties Compounding Pharmacy, Augusta, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Mar 2013
- FDA classified
- 3 Jul 2013
- Reported
- 10 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Hormones & Birth Control
Timeline
| 20 Mar 2013 | Recall initiated by company | |
| 3 Jul 2013 | Classified by FDA | +105 days |
| 10 Jul 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Estradiol Valerate 20 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Where it was distributed
FL, GA and SC.
Questions about this recall
Is Estradiol Valerate 20 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road recalled?
Yes. Clinical Specialties Compounding Pharmacy recalled Estradiol Valerate 20 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road on 20 Mar 2013. The recall is Class II and its status is Terminated. Recall number D-640-2013.
Why was it recalled?
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Which lots are affected?
Lot number CABCADBA:96, Exp date: 4/1/2013 and Lot number CABCAIBA:31, Exp date: 4/6/2013.
Where was it sold?
FL, GA and SC.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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