Why it was recalled
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product description
Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Lot numbers, UPCs & expiration codes
All Lots
Where it was sold
Florida, California, Minnesota, and Maine
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-565-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 2, 2013
- FDA report date
- Jun 12, 2013
- Quantity
- 32 vials of 50mL
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- THE COMPOUNDING SHOP, INC.
Original FDA data
Every field from FDA enforcement report D-565-2013, exactly as published.
Show all FDA fields
- City
- St Petersburg
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 65125
- Address
- 4000 Park St N
- Code information
- All Lots
- Postal code
- 33709-4034
- Report date
- Jun 12, 2013
- Product type
- Drugs
- Recall number
- D-565-2013
- Classification
- Class II
- Recalling firm
- THE COMPOUNDING SHOP, INC.
- Product quantity
- 32 vials of 50mL
- Termination date
- Sep 30, 2024
- 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
- Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
- Distribution pattern
- Florida, California, Minnesota, and Maine
- Recall initiation date
- May 2, 2013
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jun 4, 2013