Why it was recalled
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product description
MIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, 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-571-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 2, 2013
- FDA report date
- Jun 12, 2013
- Quantity
- 10 vials of 30 mL each
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- THE COMPOUNDING SHOP, INC.
Original FDA data
Every field from FDA enforcement report D-571-2013, 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-571-2013
- Classification
- Class II
- Recalling firm
- THE COMPOUNDING SHOP, INC.
- Product quantity
- 10 vials of 30 mL each
- 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
- MIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, 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