CLASS II Drug recall · Reported 10 Jul 2013 · FDA Enforcement Report
Estradiol Cypionate 5 mg/ml recalled by Clinical Specialties
Clinical Specialties Compounding Pharmacy is recalling Estradiol Cypionate 5 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-639-2013
- 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 Cypionate 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Where it was distributed
FL, GA and SC.
Questions about this recall
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 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.
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.
Other products in this recall event
48 other products · FDA event 64661This product is part of a recall event; the main page for the event is Progesterone 50 mg/ml, Clinical Specialties Compounding recalled.
More recalls from Clinical Specialties Compounding Pharmacy
All 50| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Avastin, 1.25 mg/, single unit dose syringes recalled | Clinical Specialties Compounding Pharmacy | Sterility | 5 states |
| Drug | CLASS II | Test cyp 35 mg/ml, Clinical Specialties Compounding recalled | Clinical Specialties Compounding Pharmacy | Sterility | FL, GA, SC |
| Drug | CLASS II | Test Cyp 50 mg-estradiol cyp 2 mg/ml recalled by Clinical Specialties | Clinical Specialties Compounding Pharmacy | Sterility | FL, GA, SC |
| Drug | CLASS II | HCG/ml syringe, Clinical Specialties Compounding Pharmacy recalled | Clinical Specialties Compounding Pharmacy | Sterility | FL, GA, SC |
| Drug | CLASS II | Itraconazole 1% eye ointment recalled by Clinical Specialties | Clinical Specialties Compounding Pharmacy | Sterility | FL, GA, SC |