D-0169-2016 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 18, 2015
- Initiation Date
- October 7, 2015
- Termination Date
- April 7, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31 -10 ml vials; 16- 5 ml vials
Product Description
PAPA+PGE1+PHENTO (30mg/20mcg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Distribution Pattern
CA and NJ
Code Information
5 mL 06022015@11, exp 11/29/2015; 06082015@5, exp 12/5/2015; 06112015@7, exp 12/8/2015; 06112015@9, exp 12/8/2015; 06162015@7, exp 12/13/2015; 07092015@6, exp 1/5/2016; 07092015@7, exp 1/5/2016; 07162015@4, exp 1/12/2016; 07202015@1, exp 1/16/2016; 07202015@2, exp 1/16/2016; 08032015@6, exp 1/30/2016; 08142015@12, exp 2/10/2016; 08142015@13, exp 2/10/2016; 08142015@7, exp 2/10/2016; 08182015@14, exp 2/14/2016; 08242015@6, exp 2/20/2016 --- 10 mL 05042015@4, exp 10/31/2015; 06012015@6, exp 11/28/2015; 06022015@12, exp 11/29/2015; 06032015@5, exp 11/30/2015; 06082015@4, exp 12/5/2015; 06082015@5, exp 12/5/2015; 06112015@4, exp 12/8/2015; 06152015@10, exp 12/12/2015; 06162015@6, exp 12/13/2015; 06232015@12, exp 12/20/2015; 07012015@1, exp 12/28/2015; 07092015@8, exp 1/5/2016; 07132015@2, exp 1/9/2016; 07152015@10, exp 1/11/2016; 07162015@6, exp 1/12/2016; 07272015@4, exp 1/23/2016; 07282015@3, exp 1/24/2016; 07282015@4, exp 1/24/2016; 07282015@5, exp 1/24/2016; 07292015@4, exp1/25/2016; 08032015@2, exp 1/30/2016; 08032015@7, exp 1/30/2016; 08142015@10, exp 2/10/2016; 08142015@11, exp 2/10/2016; 08142015@2, exp 2/10/2016; 08142015@4, exp 2/10/2016; 08142015@6, exp 2/10/2016; 08142015@8, exp 2/10/2016; 08182015@12, exp 2/14/2016; 08182015@13, exp 2/14/2016; 08312015@4, exp 2/20/2016