Why it was recalled
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product description
Diphenhydramine 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Lot numbers, UPCs & expiration codes
A3804 Exp 12/31/13
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-723-2013
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 29, 2013
- FDA report date
- Jul 17, 2013
- Quantity
- 1
- 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-723-2013, 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
- A3804 Exp 12/31/13
- Postal code
- 32835-3500
- Report date
- Jul 17, 2013
- Product type
- Drugs
- Recall number
- D-723-2013
- Classification
- Class II
- Recalling firm
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Product quantity
- 1
- 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
- Diphenhydramine 50 mg/ml Injection, 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