FDAFDA · Food and drugs·Recall number D-0170-2016
PAPA/PHENTO (30mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
Published November 18, 2015 · Recall initiated: October 7, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Pacific Healthcare, Inc dba B&B Pharmacy
- Distributor
- CA and NJ
- Lot
- 5 ml --- 07212015@2, exp 1/17/2016; 10 ml --- 05062015@17, exp 11/2/2015; 07082015@10, exp 1/4/2016; 08312015@3, exp 2/20/2016
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States