Why it was recalled
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.
Product description
NA. Phenylbutyrate 200 mg/mL, SDV, a) 10 mL, b) 25 mL, and c) 50 mL, WELLNESS PHARMACY, 1-800-227-2627
Lot numbers, UPCs & expiration codes
Lot# 130621@28, Use by: 10/19/2013
Where it was sold
Nationwide and Puerto Rico
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-1033-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 23, 2013
- FDA report date
- Sep 18, 2013
- Quantity
- 200 Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Wellness Pharmacy, Inc.
Original FDA data
Every field from FDA enforcement report D-1033-2013, exactly as published.
Show all FDA fields
- City
- Birmingham
- State
- AL
- Status
- Terminated
- Country
- United States
- Event ID
- 66188
- Address
- 3401 Independence Drive Suite 231
- Code information
- Lot# 130621@28, Use by: 10/19/2013
- Postal code
- 35209-8326
- Report date
- Sep 18, 2013
- Product type
- Drugs
- Recall number
- D-1033-2013
- Classification
- Class II
- Recalling firm
- Wellness Pharmacy, Inc.
- Product quantity
- 200 Vials
- Termination date
- Jun 3, 2014
- Reason for recall
- Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- NA. Phenylbutyrate 200 mg/mL, SDV, a) 10 mL, b) 25 mL, and c) 50 mL, WELLNESS PHARMACY, 1-800-227-2627
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Aug 23, 2013
- Initial firm notification
- Telephone
- Center classification date
- Sep 12, 2013