Class II
Terminated
PAPA/PGE1/PHENTO (15mg/5mcg/0.5mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
- Recall Initiated
- October 7, 2015
- Posted
- November 18, 2015
- Recall Number
- D-0176-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1- 5ml vial, 1- 10 ml vial
- Firm Location
- Bellflower, CA, United States
Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Distribution
CA and NJ
Lot / Code Info
5 ml --- 07062015@1, exp 1/2/2016; ---- 10 ml --- 07272015@3, exp 1/23/2016
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