Why it was recalled
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product description
Test Cyp 100 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot numbers, UPCs & expiration codes
Lot number CABCBFBA:15, Exp date: 4/13/2013; Lot number CABCACBA:58, Exp date: 3/31/2013; Lot number CABCAHBB:54, Exp date: 5/6/2013; Lot number CABCCHBB:63, Exp date: 5/26/2013; Lot number CABCAFBC:31, Exp date: 6/3/2013; Lot number CABCCHBS:23, Exp date: 6/25/2013; Lot number CABDBAAB:64, Exp date: 7/9/2013; Lot number CABDAIAB:59, Exp date: 7/7/2013; Lot number CABDAFAC:48, Exp date: 8/4/2013; Lot number CABDBJAC:27, Exp date: 8/18/2013 and Lot number CABDABAD:61, Exp date: 8/28/2013.
Where it was sold
FL, GA and SC.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-665-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 20, 2013
- FDA report date
- Jul 10, 2013
- Quantity
- 219ml total
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Clinical Specialties Compounding Pharmacy
Original FDA data
Every field from FDA enforcement report D-665-2013, exactly as published.
Show all FDA fields
- City
- Augusta
- State
- GA
- Status
- Terminated
- Country
- United States
- Event ID
- 64661
- Address
- 318 Baston Rd
- Code information
- Lot number CABCBFBA:15, Exp date: 4/13/2013; Lot number CABCACBA:58, Exp date: 3/31/2013; Lot number CABCAHBB:54, Exp date: 5/6/2013; Lot number CABCCHBB:63, Exp date: 5/26/2013; Lot number CABCAFBC:31, Exp date: 6/3/2013; Lot number CABCCHBS:23, Exp date: 6/25/2013; Lot number CABDBAAB:64, Exp date: 7/9/2013; Lot number CABDAIAB:59, Exp date: 7/7/2013; Lot number CABDAFAC:48, Exp date: 8/4/2013; Lot number CABDBJAC:27, Exp date: 8/18/2013 and Lot number CABDABAD:61, Exp date: 8/28/2013.
- Postal code
- 30907
- Report date
- Jul 10, 2013
- Product type
- Drugs
- Recall number
- D-665-2013
- Classification
- Class II
- Recalling firm
- Clinical Specialties Compounding Pharmacy
- Product quantity
- 219ml total
- Termination date
- Feb 22, 2017
- Reason for recall
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Test Cyp 100 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Distribution pattern
- FL, GA and SC.
- Recall initiation date
- Mar 20, 2013
- Initial firm notification
- Telephone
- Center classification date
- Jul 3, 2013