Why it was recalled
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Product description
MULTITRACE-5 INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
Lot numbers, UPCs & expiration codes
02082013@10 and 07162013@10
Where it was sold
USA nationwide
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-982-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 26, 2013
- FDA report date
- Sep 18, 2013
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Beacon Hill Medical Pharmacy, P.C.
Original FDA data
Every field from FDA enforcement report D-982-2013, exactly as published.
Show all FDA fields
- City
- Southfield
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 65876
- Address
- 18161 W 13 Mile Rd
- Address (line 2)
- Suite A1
- Code information
- 02082013@10 and 07162013@10
- Postal code
- 48076-1113
- Report date
- Sep 18, 2013
- Product type
- Drugs
- Recall number
- D-982-2013
- Classification
- Class II
- Recalling firm
- Beacon Hill Medical Pharmacy, P.C.
- Termination date
- Jul 18, 2014
- Reason for recall
- Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- MULTITRACE-5 INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
- Distribution pattern
- USA nationwide
- Recall initiation date
- Jul 26, 2013
- Initial firm notification
- Telephone
- Center classification date
- Sep 10, 2013