Home / Recalls / Pacific Healthcare, Inc dba B&B Pharmacy / D-0176-2016

D-0176-2016 Class II Terminated

Recalled by Pacific Healthcare, Inc dba B&B Pharmacy — Bellflower, CA

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
1- 5ml vial, 1- 10 ml vial

Product Description

PAPA/PGE1/PHENTO (15mg/5mcg/0.5mg/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 --- 07062015@1, exp 1/2/2016; ---- 10 ml --- 07272015@3, exp 1/23/2016

Other recalls by Pacific Healthcare, Inc dba B&B Pharmacy

  • D-0168-2016 Class II — Testosterone prop. 200 mg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pharma (October 7, 2015)
  • D-0167-2016 Class II — Testosterone Cypionate 250 mg/mL Injection, 10 mL vial, Rx, B & B Health Mart Ph (October 7, 2015)
  • D-0171-2016 Class II — PGE 20mcg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, (October 7, 2015)
  • D-0170-2016 Class II — PAPA/PHENTO (30mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart (October 7, 2015)
  • D-0175-2016 Class II — PAPA/PGE1/PHENTO (30mg/40mcg/1mg/ml) Injection, 10 mL vial, Rx, B & B Health Mar (October 7, 2015)
  • D-0174-2016 Class II — PAPA/PGE1/PHENTO (30mg/10mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B H (October 7, 2015)
  • D-0177-2016 Class II — PGE 30mcg/ml Injection, 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, (October 7, 2015)
  • D-0172-2016 Class II — PAPA/PGE1/PHENTO (30mg/50mcg/0.5mg/ml), Injection, 10 mL vial, Rx, B & B Health (October 7, 2015)
  • D-0178-2016 Class II — PAPA/PHENTO (15mg/0.8333mg/ml) Injection, 5 mL vial, Rx, B & B Health Mart Pharm (October 7, 2015)
  • D-0169-2016 Class II — PAPA+PGE1+PHENTO (30mg/20mcg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B (October 7, 2015)