Why it was recalled
Lack of Assurance of Sterility
Product description
HYDROXYZINE HYDROCHLORIDE (30ML VIAL) (STERILE WATER) 50MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
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-1099-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 18, 2015
- FDA report date
- Jun 3, 2015
- Quantity
- 3 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Advanced Physician Solutions, Inc.
Original FDA data
Every field from FDA enforcement report D-1099-2015, exactly as published.
Show all FDA fields
- City
- N Hollywood
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 71205
- Address
- 7225 Fulton Ave
- Code information
- All lots
- Postal code
- 91605-4111
- Report date
- Jun 3, 2015
- Product type
- Drugs
- Recall number
- D-1099-2015
- Classification
- Class II
- Recalling firm
- Advanced Physician Solutions, Inc.
- Product quantity
- 3 vials
- Termination date
- Nov 16, 2015
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HYDROXYZINE HYDROCHLORIDE (30ML VIAL) (STERILE WATER) 50MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
- Distribution pattern
- Nationwide
- Recall initiation date
- May 18, 2015
- Initial firm notification
- Letter
- Center classification date
- May 28, 2015