Why it was recalled
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product description
Trimix, compounded by Olympia Pharmacy, Orlando, FL
Lot numbers, UPCs & expiration codes
B5015 Exp 8/15/13, C50001 Exp 8/28/13, B5011 Exp 8/1/13, C42215 Exp 6/22/13, A5028 Exp 6/2/13, B5011 Exp 6/1/13, B5020 Exp 6/1/13, B50112 Exp 8/11/13, C4186 Exp 6/18/13, C4158 Exp 6/15/13, C4149 Exp 6/14/13, C4111 Exp 6/11/13, B4124 Exp 8/12/13, B4154 Exp 8/15/13, B4198 Exp 8/19/13, B4226 Exp 8/22/13, B4268 Exp 8/22/13, C40522 Exp 9/5/13, C4118 Exp 9/1/13, C4711 Exp 9/7/13, C41121 Exp 9/11/13, C4126 Exp 9/12/13 and B42715 Exp 8/27/13.
Where it was sold
Nationwide and PR
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-787-2013
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 29, 2013
- FDA report date
- Jul 17, 2013
- Quantity
- 24
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Original FDA data
Every field from FDA enforcement report D-787-2013, exactly as published.
Show all FDA fields
- City
- Orlando
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 65360
- Address
- 6700 Conroy Windermere Rd
- Address (line 2)
- Suite 140
- Code information
- B5015 Exp 8/15/13, C50001 Exp 8/28/13, B5011 Exp 8/1/13, C42215 Exp 6/22/13, A5028 Exp 6/2/13, B5011 Exp 6/1/13, B5020 Exp 6/1/13, B50112 Exp 8/11/13, C4186 Exp 6/18/13, C4158 Exp 6/15/13, C4149 Exp 6/14/13, C4111 Exp 6/11/13, B4124 Exp 8/12/13, B4154 Exp 8/15/13, B4198 Exp 8/19/13, B4226 Exp 8/22/13, B4268 Exp 8/22/13, C40522 Exp 9/5/13, C4118 Exp 9/1/13, C4711 Exp 9/7/13, C41121 Exp 9/11/13, C4126 Exp 9/12/13 and B42715 Exp 8/27/13.
- Postal code
- 32835-3500
- Report date
- Jul 17, 2013
- Product type
- Drugs
- Recall number
- D-787-2013
- Classification
- Class II
- Recalling firm
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Product quantity
- 24
- 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
- Trimix, compounded by Olympia Pharmacy, Orlando, FL
- Distribution pattern
- Nationwide and PR
- Recall initiation date
- May 29, 2013
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jul 11, 2013