PAPA+PGE1+PHENTO (30mg/20mcg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
Reported: November 18, 2015 Initiated: October 7, 2015 #D-0169-2016
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
Details
- Recalling Firm
- Pacific Healthcare, Inc dba B&B Pharmacy
- Units Affected
- 31 -10 ml vials; 16- 5 ml vials
- Distribution
- CA and NJ
- Location
- Bellflower, CA
Frequently Asked Questions
What product was recalled? ▼
PAPA+PGE1+PHENTO (30mg/20mcg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA. Recalled by Pacific Healthcare, Inc dba B&B Pharmacy. Units affected: 31 -10 ml vials; 16- 5 ml vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 18, 2015. Severity: Moderate. Recall number: D-0169-2016.
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