FDA Drug recall D-0169-2016

PAPA+PGE1+PHENTO (30mg/20mcg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA

FDA Drug
Class II
terminated
Published 2015-11-18

On 2015-11-18 the FDA classified a Class II recall of PAPA+PGE1+PHENTO (30mg/20mcg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA by Pacific Healthcare, citing lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-0169-2016
Classification	Class II
Status	terminated
Initiated	2015-10-07
Published	2015-11-18
Last updated	2026-09-13 11:51 UTC
Company	Pacific Healthcare
Distribution	CA, NJ

Product

PAPA+PGE1+PHENTO (30mg/20mcg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA

Reason

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Identifiers

code_info	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;… 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;

code_info

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;…

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;

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0169-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.