FDA Drug recall D-0170-2016
PAPA/PHENTO (30mg/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/PHENTO (30mg/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-0170-2016 |
| 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/PHENTO (30mg/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 --- 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 |
|---|
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-0170-2016%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.