Why it was recalled
Lack of Assurance of Sterility; potential for mold contamination
Product description
All Compounded Products, packaged in plastic infusion bags, devices, syringes and glass vials, Med Prep Consulting Inc., Tinton Falls, NJ 07712
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
Press States Nationwide. Distribution List indicates the following: DE, FL, IL, IN, ME, MI, NJ, PA, TX, and VA
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-811-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 14, 2013
- FDA report date
- Jul 31, 2013
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Med Prep Consulting, Inc.
Original FDA data
Every field from FDA enforcement report D-811-2013, exactly as published.
Show all FDA fields
- City
- Tinton Falls
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 64640
- Address
- 1540 W Park Ave Ste 5
- Code information
- All lots
- Postal code
- 07712-3192
- Report date
- Jul 31, 2013
- Product type
- Drugs
- Recall number
- D-811-2013
- Classification
- Class II
- Recalling firm
- Med Prep Consulting, Inc.
- Termination date
- May 11, 2018
- Reason for recall
- Lack of Assurance of Sterility; potential for mold contamination
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- All Compounded Products, packaged in plastic infusion bags, devices, syringes and glass vials, Med Prep Consulting Inc., Tinton Falls, NJ 07712
- Distribution pattern
- Press States Nationwide. Distribution List indicates the following: DE, FL, IL, IN, ME, MI, NJ, PA, TX, and VA
- Recall initiation date
- Mar 14, 2013
- Initial firm notification
- Telephone
- Center classification date
- Jul 19, 2013