Multi-event October 2015 FDA Recall Drug by Pacific Healthcare, Inc Dba B&b Pharmacy

This Multi-event Class II drug recall was voluntarily initiated by Pacific Healthcare, Inc Dba B&b Pharmacy on October 7, 2015 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility; fda inspection identified gmp violations potentially impacting product quality and sterility. The product was distributed in CA and NJ and the recall is currently terminated.

Reported Recall Events

Recall Number: D-0176-2016

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
10-07-2015
Reported
11-18-2015
Quantity
1- 5ml vial, 1- 10 ml vial

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pacific Healthcare, Inc dba B&B Pharmacy
PAPA/PGE1/PHENTO (15mg/5mcg/0.5mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA

Batch or Lot Expiration Information

Lot# 5 ml --- 07062015@1, exp 1/2/2016; ---- 10 ml --- 07272015@3, exp 1/23/2016

Recall Number: D-0168-2016

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
10-07-2015
Reported
11-18-2015
Quantity
2 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pacific Healthcare, Inc dba B&B Pharmacy
Testosterone prop. 200 mg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA

Batch or Lot Expiration Information

Lot# 07282015@8, exp 10/26/2015, 07302015@4, exp 10/28/2015

Recall Number: D-0167-2016

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
10-07-2015
Reported
11-18-2015
Quantity
3 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pacific Healthcare, Inc dba B&B Pharmacy
Testosterone Cypionate 250 mg/mL Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA

Batch or Lot Expiration Information

Lot# 07282015@7, exp 10/26/2015, 07292015@6, 10/27/2015, 08252015@4, 11/23/2015

Recall Number: D-0179-2016

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
10-07-2015
Reported
11-18-2015
Quantity
1 vial

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pacific Healthcare, Inc dba B&B Pharmacy
PAPA/PGE1/PHENTO (35mg/12mcg/1.5mg/ml), Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA

Batch or Lot Expiration Information

Lot# 08032015@4, exp 1/30/2016

Recall Number: D-0171-2016

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
10-07-2015
Reported
11-18-2015
Quantity
3 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pacific Healthcare, Inc dba B&B Pharmacy
PGE 20mcg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA

Batch or Lot Expiration Information

Lot# 05072015@7, exp 11/3/2015; 05182015@3, 11/14/2015; 07152015@, 1/11/2016

Recall Number: D-0173-2016

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
10-07-2015
Reported
11-18-2015
Quantity
1 vial

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pacific Healthcare, Inc dba B&B Pharmacy
PAPA/PGE1/PHENTO (22.5mg/8.33mcg/0.833mg/ml) Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA

Batch or Lot Expiration Information

Lot# 06012015@8, exp 11/28/2015

Recall Number: D-0170-2016

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
10-07-2015
Reported
11-18-2015
Quantity
1-5 ml vial, 3-10 ml vial

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pacific Healthcare, Inc dba B&B Pharmacy
PAPA/PHENTO (30mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA

Batch or Lot Expiration Information

Lot# 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

Recall Number: D-0166-2016

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
10-07-2015
Reported
11-18-2015
Quantity
2-10ml vials, 1-20ml vial

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pacific Healthcare, Inc dba B&B Pharmacy
Nandrolone 200 mg/ml Injection, 10 mL and 20 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA

Batch or Lot Expiration Information

Lot# 10 ml-- 05252015@2, exp 10/23/2015; 06252015@2, exp 10/23/2015 20 mL-- 06252015@2, exp 10/23/2015

Recall Number: D-0175-2016

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
10-07-2015
Reported
11-18-2015
Quantity
1 vial

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pacific Healthcare, Inc dba B&B Pharmacy
PAPA/PGE1/PHENTO (30mg/40mcg/1mg/ml) Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA

Batch or Lot Expiration Information

Lot# 07022015@3, exp 12/29/2015

Recall Number: D-0174-2016

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
10-07-2015
Reported
11-18-2015
Quantity
1-5 ml vial; 3-10 ml vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pacific Healthcare, Inc dba B&B Pharmacy
PAPA/PGE1/PHENTO (30mg/10mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA

Batch or Lot Expiration Information

Lot# 5 ml --- 07062015@2, exp 1/2/2016 10 ml --- 06042015@4, exp 12/1/2015; 06052015@15, exp 12/2/2015; 07132015@3, exp 1/9/2016

Recall Number: D-0165-2016

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
10-07-2015
Reported
11-18-2015
Quantity
2 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pacific Healthcare, Inc dba B&B Pharmacy
Stanozolol 200 mg/ml Injection, 20 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA

Batch or Lot Expiration Information

Lot# 07162015@3, exp 10/14/2015, 08112015@1, exp 11/9/2015

Recall Number: D-0177-2016

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
10-07-2015
Reported
11-18-2015
Quantity
4 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pacific Healthcare, Inc dba B&B Pharmacy
PGE 30mcg/ml Injection, 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA

Batch or Lot Expiration Information

Lot# 07062015@8, exp 1/2/2016; 07162015@7, exp 1/12/2016; 07272015@5, exp 1/23/2016; 08142015@9, exp 2/10/2016

Recall Number: D-0172-2016

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
10-07-2015
Reported
11-18-2015
Quantity
1 vial

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pacific Healthcare, Inc dba B&B Pharmacy
PAPA/PGE1/PHENTO (30mg/50mcg/0.5mg/ml), Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA

Batch or Lot Expiration Information

Lot# 06012015@7, exp 11/28/2015

Recall Number: D-0180-2016

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
10-07-2015
Reported
11-18-2015
Quantity
1 vial

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pacific Healthcare, Inc dba B&B Pharmacy
PGE 25mcg/ml, Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA

Batch or Lot Expiration Information

Lot# 08242015@5, exp 2/20/2016

Recall Number: D-0178-2016

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
10-07-2015
Reported
11-18-2015
Quantity
1 vial

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pacific Healthcare, Inc dba B&B Pharmacy
PAPA/PHENTO (15mg/0.8333mg/ml) Injection, 5 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA

Batch or Lot Expiration Information

Lot# 07082015@4, exp 1/5/2016

Recall Number: D-0169-2016

Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Initiated
10-07-2015
Reported
11-18-2015
Quantity
31 -10 ml vials; 16- 5 ml vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Pacific Healthcare, Inc dba B&B Pharmacy
PAPA+PGE1+PHENTO (30mg/20mcg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA

Batch or Lot Expiration Information

Lot# 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