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
PARABEN WATER FOR INJECTION, 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
04012013@21, 07252013@15
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-987-2013
- 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-987-2013, 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
- 04012013@21, 07252013@15
- Postal code
- 48076-1113
- Report date
- Sep 18, 2013
- Product type
- Drugs
- Recall number
- D-987-2013
- 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
- PARABEN WATER FOR INJECTION, 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