Why it was recalled
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product description
Ophthalmic dilation gel, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot numbers, UPCs & expiration codes
Lot number CABDBDAC:11, Exp date: 8/12/2013; Lot number CABCCHAJ:28, Exp date: 3/26/2013; Lot number CABCBBBA:57, Exp date: 4/9/2013; Lot number CABCCGBA:11, Exp date: 4/24/2013; Lot number CABCACBB:26, Exp date: 5/1/2013; Lot number CABCBGBB:54, Exp date: 5/15/2013; Lot number CABCCJBB:38, Exp date: 5/28/2013; Lot number CABCBDBC:40, Exp date: 6/11/2013; Lot number CABCCIBC:73, Exp date: 6/26/2013; Lot number CABDBBAB:32, Exp date: 7/10/2013; Lot number CABDCEAB:92, Exp date: 7/23/2013; Lot number CABDAHAC:76, Exp date: 8/6/2013; Lot number CABDCBAC:11, Exp date: 8/20/2013 and Lot number CABDAHAD:85, Exp date: 9/3/2013.
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-658-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 20, 2013
- FDA report date
- Jul 10, 2013
- Quantity
- 378ml total
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Clinical Specialties Compounding Pharmacy
Original FDA data
Every field from FDA enforcement report D-658-2013, 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 CABDBDAC:11, Exp date: 8/12/2013; Lot number CABCCHAJ:28, Exp date: 3/26/2013; Lot number CABCBBBA:57, Exp date: 4/9/2013; Lot number CABCCGBA:11, Exp date: 4/24/2013; Lot number CABCACBB:26, Exp date: 5/1/2013; Lot number CABCBGBB:54, Exp date: 5/15/2013; Lot number CABCCJBB:38, Exp date: 5/28/2013; Lot number CABCBDBC:40, Exp date: 6/11/2013; Lot number CABCCIBC:73, Exp date: 6/26/2013; Lot number CABDBBAB:32, Exp date: 7/10/2013; Lot number CABDCEAB:92, Exp date: 7/23/2013; Lot number CABDAHAC:76, Exp date: 8/6/2013; Lot number CABDCBAC:11, Exp date: 8/20/2013 and Lot number CABDAHAD:85, Exp date: 9/3/2013.
- Postal code
- 30907
- Report date
- Jul 10, 2013
- Product type
- Drugs
- Recall number
- D-658-2013
- Classification
- Class II
- Recalling firm
- Clinical Specialties Compounding Pharmacy
- Product quantity
- 378ml 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
- Ophthalmic dilation gel, 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