Why it was recalled
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product description
Laser ophthalmic drops, 12 mL bottle, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Lot numbers, UPCs & expiration codes
Lot number CABCCIBC:20, Exp date: 3/28/2013 and Lot number CABDAEAC:90, Exp date: 3/5/2013.
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-649-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 20, 2013
- FDA report date
- Jul 10, 2013
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Clinical Specialties Compounding Pharmacy
Original FDA data
Every field from FDA enforcement report D-649-2013, 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 CABCCIBC:20, Exp date: 3/28/2013 and Lot number CABDAEAC:90, Exp date: 3/5/2013.
- Postal code
- 30907
- Report date
- Jul 10, 2013
- Product type
- Drugs
- Recall number
- D-649-2013
- Classification
- Class II
- Recalling firm
- Clinical Specialties Compounding Pharmacy
- 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
- Laser ophthalmic drops, 12 mL bottle, 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